8 ms·

Irregularities found during FDA inspection of Intas Pharmaceuticals

dmm 3y ago
If you're interested in the safety of generic drugs you should read "Bottle of Lies" by Katherine Eban. She presents a convincing argument that FDA regulators were/are unprepared for ensuring the safety of drugs from overseas manufacturers. For example, in the US, drug makers are subject to surprise inspections but in India and China, manufacturers have weeks or MONTHS of warning. There was a program to station inspector in India and perform random inspections but it was cancelled. She argues because it was too effective, every plant inspected was found to have serious issues. And it's not just ignorance of good manufacturing practices or a few bad actors. She shares the story of whistleblower Dinesh Thakur who revealed Ranbaxy executives committing safety-compromising fraud.
- jiggawatts 3y ago
  I did an IT consulting gig at a western pharma company that specialises in generics. They develop the chemistry and the manufacturing process at the head office, and then pack up the factory and ship it to India or China for low-cost operation. I overheard an emergency conference meeting about a batch that had gone bad. I can't remember the details, it overheated or something like that, certainly ruining some horrifically complicated organic chemistry process step. The Indian chemical engineers were arguing for hours about how they could "save" the batch or "use it somehow" while the westerners were repeatedly telling them that there is no safe way to do that, and the only option was the throw it out and start from the beginning. "Sir, we can fix it!" "No, no, no! Throw it out!" ... for hours. Their culture is just not compatible with certain modes of thinking, like "safety first". Saving face takes priority in their culture, even if that means kids might die because the drug batch was bad.
  - api 3y ago
    Why is it so much cheaper in India or China? Labor cost? No EPA? It has to be so cheap that the cost of offshoring and coordinating all that is dwarfed by the savings.
    - alephnerd 3y ago
      IP Enforcement. If I'm a European, Israeli, or Japanese conglomerate that wants to make a clone of Pfizer or Abbott compounds, I can't do that in the EU or US+Canada because I'd be sued for patent infringement. On the other hand, India, Israel, and Japan don't recognize or enforce American patents for pharmacuticals. After Israel and Japan became developed countries in the 80s-90s, it became expensive to manufacture within both, so the Pharma companies like Teva and Takeda began investing heavily in the Indian Pharma manufacturing base in the Himachal Pradesh-Chandigarh-Haryana-Uttarakhand corridor and the Hyderabad-Pune corridor.
      - unmole 3y ago
        Yeah, no. If what you said was true, The Serum Institute of India wouldn't have licensed the Oxford-AZ vaccine. Same applies for drugs like Molnupiravir where local manufacturers licenced the drug from Merck. Even if these manufacturers were able to get away with patent violations, they still wouldn't be able to export them to the biggest and richest markets.
        alephnerd 3y ago
        The COVID vaccine was a bad example as it was manufacted on license from AstraZeneca, but the larger Indian market absolutely does this due to how the Indian Patent Act is structured. "Section 3(d) of the Patents Act, 1970, explains that a new form of a known substance, new property / new use for a known substance and the mere use of a known process are not patentable and is not considered distinct from the known substance. Based on this principle, inventions using known substances are not patentable unless, for example, the alleged invention displays a significant increase in efficacy." [0] Ranbaxy, Reddy Labs, and Sun Pharma all started thanks to this loophole, and it has been a massive blocker in any US-India Free Trade Agreement. This is all open knowledge to all players in the India market [1]. It's not necessarily a bad thing btw - it's a major reason India's Pharma and Agrochemical R&D pipeline punches above its weight, but it has an impact on US-India relations, but for other regions such as the EU, Japan, or Developing countries it doesn't have much of an impact. [0] https://www.aipla.org/list/innovate-articles/the-global-significance-of-india-s-pharmaceutical-patent-laws https://www.aipla.org/list/innovate-articles/the-global-sign... [1] https://www.nishithdesai.com/fileadmin/user_upload/pdfs/Patents_and_the_Indian_Pharmaceutical_Industry.pdf https://www.nishithdesai.com/fileadmin/user_upload/pdfs/Pate...
  - PaywallBuster 3y ago
    We may need nearshore/onshore QC
    - alephnerd 3y ago
      That's how the FDA operates. That's why the filing above was created by the FDA. You'll have some level of surprise inspections in India, and another set when the batch is imported to the US or EU.
      - delfinom 3y ago
        That is not how the FDA operates. For more than 2 decades, the FDA has basically given these overseas generic factories months of advanced notice of inspections. There are even former inspector who tried to whistleblower over how many times theyve caught those factories fabricating data and other circumstnaces and the FDA just buried the issue. The real question, what in the world changed that made the FDA decide to suddenly cause the effective discontinuation of chemo as a treatment option for the US LOL
    - mwbajor 3y ago
      Its ok to subsidize banks in the US, but we can't subsidize manufacturing (like every other country) for some reason.
      - Slava_Propanei 3y ago
        [dead]
  - alephnerd 3y ago
    > Saving face takes priority in their culture To an outsider it looks like saving face, but it really isn't - it's self preservation. Asian business culture doesn't have the concept of "Blameless Post-mortems". If a batch was mismanufactered, the GM at the plant would have heads roll because margins are so low.
  - londons_explore 3y ago
    > kids might die because the drug batch was bad. You need to trade that off with 'kids might die because the drug batch was thrown out.' In any supply and demand market, any supplier chucking out product means some buyer somewhere is priced out of the goods they would have bought. If the faulty drugs were even 50% as effective as good drugs, then more lives were probably saved by shipping them. The problem is that there is no way to find those people who would have been priced out and offer them the maybe-50%-effective-maybe-deadly drugs.
    - kneebonian 3y ago
      Is your argument really "we should let people take dangerous and potentially deadly pharmaceuticals to reduce costs." Because I agree that would reduce cost by dropping demand.... Because the people taking them would be dead.
    - salad-tycoon 3y ago
      > If the faulty drugs were even 50% as effective as good drugs, then more lives were probably saved by shipping them. The problem is that there is no way to find those people who would have been priced out and offer them the maybe-50%-effective-maybe-deadly drugs. Huh? You are assuming that they are effective at all and, even worse, let’s assume that it is 50% effective intended drug dose what the hell is in the other 50%?! Does it cause cancer or lead to other disease? Is it innocuous? Frequently contaminants are really not. Look up Chanticleer, Metformin, ranitidine just in the last couple of years. These aren’t expired medications. They are ineffective at an overly generous best and likely dangerous. These also aren’t street dealers where you are okay if 50% is coke and 50% is flour. No pharma company is your friend. They can be useful, sure.
    - HarryHirsch 3y ago
      A bad batch of a drug or precursor does not conform to standards is no good in a safety-critical industry. We are looking at generic drugs, it's not like you have a batch of polyethylene from the pilot plant which does not conform to any standard, and you send it off to SE Asia for use in cheap plastic toys.
  - PeterStuer 3y ago
    If by 'their culture' you mean the culture of market capitalism you might be right. What do you think happens to batches of products that exceed certain pollutant treshholds in the US or the EU or anywhere else? They are destroyed? No. They get diluted into other batches until they just meet the tresholds of the allowed percentages.
- causality0 3y ago
  How do you find out where your bottle of generic pills was made?
  - alephnerd 3y ago
    It should have the plant name on the bottle or box itself generally.
crispyambulance 3y ago
There's a lot of details in there related to manufacturing of pharmaceuticals, it's not clear how egregious these irregularities actually are to people that don't know this stuff. So... what does Intas make? What is "an irregularity", what does it mean in plain language? How bad was it there? Is this going to end up as just needing corrective action, or is Intas now barred from selling in the US?
- chromatin 3y ago
  For perspective, the document indicates their manufacturing area which was supposed to be sterile had bacteria and/or fungus growing on sentinel culture plates.
- tobsterius 3y ago
  A whole lot of stuff... https://www.accordhealthcare.us/products/ https://www.accordhealthcare.us/products/ (Their main page, https://www.intaspharma.com/products/ https://www.intaspharma.com/products/, links to that URL above for the US-specific market.)
- emodendroket 3y ago
  I think most people can understand that re-runninf quality checks to fudge the results and destroying records as soon as you realize inspectors have arrived is pretty bad.
- HillRat 3y ago
  This is pretty indicative of how bad things are: [A] quality control officer ... alleg[ed to investigators] another employee -- upon learning investigators were on the way -- "immediately rushed and tore apart balance printouts along with Auto Titrator spectrums and threw the torn pieces into the small trash container,” which the employee then doused with an acid solution in a bid to “destroy the evidence of tests" with potentially damning results. (https://www.fiercepharma.com/manufacturing/burn-after-reading-fda-blasts-intas-cascade-failures-after-investigators-find-heaps https://www.fiercepharma.com/manufacturing/burn-after-readin...) Intas is under an import alert for most of their drugs, but FDA is allowing twenty-five short-supply drugs (including a lot of chemo drugs) to be imported, which should also tell you how stressed the pharma supply chain is right now.
mhalle 3y ago
Here's another in-depth article on the safety issues surrounding a particular generic for the drug tacrolimus (Prograf is the non-generic drug). https://www.bostonglobe.com/ideas/2019/05/24/ideas-katherine-eban-these-pills-could-kill-you/d4gYXkoMR24n1uoLUkbnqJ/story.html https://www.bostonglobe.com/ideas/2019/05/24/ideas-katherine... https://archive.is/2023.02.27-233237/https://www.bostonglobe.com/ideas/2019/05/24/ideas-katherine-eban-these-pills-could-kill-you/d4gYXkoMR24n1uoLUkbnqJ/story.html https://archive.is/2023.02.27-233237/https://www.bostonglobe...
A_D_E_P_T 3y ago
The FDA's regulatory scheme is absolutely backwards. Investigating foreign facilities and forcing manufacturers to comply with onerous paperwork and recordkeeping details does little or nothing to ensure the availability, quality, and low cost of generic drugs. (In fact, you could argue that it does just the opposite, in reducing availability and increasing cost, with at best indifferent results where drug quality is concerned.) Instead, the FDA should test a statistically valid random sample of any given drug _upon its import and introduction to the US pharmaceutical supply chain._ This would be considerably less expensive for all involved, less demanding and even demeaning for all involved, and of far greater relevance to the quality and safety of the drugs available on the US market.
- robg 3y ago
  You don’t mention quality controls. What should FDA do if upon said random testing there are concerns? How can they and/or the manufacturer trace the causes without documentation?
  - A_D_E_P_T 3y ago
    > What should FDA do if upon said random testing there are concerns? Destroy or return the entire batch, depending on the level of concern. > How can they and/or the manufacturer trace the causes without documentation? That shouldn't be the FDA's concern. The FDA's concern should begin and end with the quality of the actual drugs that are entering the US supply chain. The drugs are things in themselves and can be tested as such -- without regard to where they came from or exactly how they were made.
    - robg 3y ago
      A random sample by definition isn’t the entire batch, so how would you define ‘batch’ without documentation? The FDA would force recall on the entire product entering the country? Until how many samples are cleared?
      - A_D_E_P_T 3y ago
derbOac 3y ago
I don't know why this is allowed to go on. It's been going on for years with almost no consequences. At one point relatively recently they threatened to cut off one generic manufacturer from the US market but then backed off, as far as I remember. They know this is a trend, it's been documented in many articles over the last decade at least. They could make unannounced spot checks, they could do more quality control sampling, they could increase accountability by mandating manufacturing information and links to safety violation records be printed on drug labels. And so forth and so on. Sometimes I feel as if the entire medical industry in the US, and especially the drug regulation culture, has its head in the clouds with either some form of regulatory capture and/or narcissistic feeling of impunity or disregard. Several years ago there was an article in a major news outlet about generics, and how lower income individuals were more likely to to choose brand name drugs over generics. The entire article, with interviews with physicians and medical experts, was framed around this idea that lower income individuals were less educated and didn't understand that generics were "chemically exactly the same" as brand names. This was going on at the same time as all this adulteration and dangerous manufacturing of generics. Not once did they mention that the possibility that maybe lower income individuals had a realistic, healthy fear of being screwed over by inferior products and lack of real oversight from authorities who are supposed to protect them. The entire article was like a snapshot of problems with healthcare in the US: impoverished individuals getting screwed over by credentialed, overprivileged individuals in authority positions who are more concerned about maintaining a fiction of superiority and regulatory capture benefits than actually thinking of protecting the individuals who actually need help. It's like cargo cult medical regulation, but with motivated ignorance. The FDA needs to focus more on safety and quality control and less on the murkier and more questionable topics around efficacy and gatekeeping access.
- mwbajor 3y ago
  "...Sometimes I feel as if the entire medical industry in the US, and especially the drug regulation culture, has its head in the clouds with either some form of regulatory capture and/or narcissistic feeling of impunity or disregard...." Why is it ok to say this about anything not covid related?
  - 3y ago
turtleyacht 3y ago
[PDF]
seatac76 3y ago
This is like the third incident in the last year. Indian government seems to be sleeping at the wheel. ITT the surprise inspection is absolutely a must. The government should step up, the negative consequences for people and industry are very bad.
ghastmaster 3y ago
Why is this redacted. FDA observations should be published in real time so that end users can make judgements and watchdog groups can evaluate and grade companies, batches, and products. That would be a better role for most federal agencies. If states want to make mandates that require adherence to some standard, that is more in line with the original constitutional role of states. I cannot say for certain, but I "feel" that these types of issues crop up quite often and are only publicized when certain corporations do not make the proper lobbying donations to certain people. Limiting the lobbying potential to a state level may prevent my "feeling".
cshimmin 3y ago
Holy smokes... "on 22-Nov-2022, when he came to know that the Investigators are on the walkthrough inspection ofBlock~t> QC laborat01y and are coming in the direction ofbalance room, he immediately rushed and tore apart balanceprintouts along with Auto Titrator spectrums and threw the torn pieces into the small trash container located next to the balance. Later, he threw1<b) < 4) -7 acid solution inside the same trash in an attempt to destroy the evidence ofthe tests that he was working on that had issues with high % RSD and weighing ofmaterial was not in line with the expectation. This trash was removed from the area immediately by your area housekeeper and moved to the QC scrap area. This trash bag was later found hidden under the staircase leading to the fb) < 4>7 floor of your QC laborato1y by another Investigator. No justification was provided upon asking by your QC management for hiding the trash bag."
delfinom 3y ago
I really wonder what triggered this inspection. Generics in the US have been a shitshow for a long time and plenty of whistleblowers from the FDA have come out over how much the FDA heads have buried the issue completely. Personally, this goes back a few years. In high school, we had a quantitative analysis class where we decomposed various brands of acetaminophen pills to measure the % of active ingredient (acetaminophen) and compare to the labeled totals. Pretty every generic brand tested by multiple groups in this lab resulted in contents below 80% of the label. I think the Rite-Aid generic was 60% of the label content. The only one even close was Tylenol coming in at 95%. (With potentially the last 5% being experiment error in recovery since we are talking milligrams and not the most extremely careful lab setup). And that's why I avoid generic acetaminophen if I want it to work LOL
willcipriano 3y ago
But god forbid we reimport drugs from Canada, they might be unsafe you see. Get them from this safe factory in India.

dmm 3y ago

If you're interested in the safety of generic drugs you should read "Bottle of Lies" by Katherine Eban. She presents a convincing argument that FDA regulators were/are unprepared for ensuring the safety of drugs from overseas manufacturers. For example, in the US, drug makers are subject to surprise inspections but in India and China, manufacturers have weeks or MONTHS of warning. There was a program to station inspector in India and perform random inspections but it was cancelled. She argues because it was too effective, every plant inspected was found to have serious issues. And it's not just ignorance of good manufacturing practices or a few bad actors. She shares the story of whistleblower Dinesh Thakur who revealed Ranbaxy executives committing safety-compromising fraud.

jiggawatts 3y ago
I did an IT consulting gig at a western pharma company that specialises in generics. They develop the chemistry and the manufacturing process at the head office, and then pack up the factory and ship it to India or China for low-cost operation. I overheard an emergency conference meeting about a batch that had gone bad. I can't remember the details, it overheated or something like that, certainly ruining some horrifically complicated organic chemistry process step. The Indian chemical engineers were arguing for hours about how they could "save" the batch or "use it somehow" while the westerners were repeatedly telling them that there is no safe way to do that, and the only option was the throw it out and start from the beginning. "Sir, we can fix it!" "No, no, no! Throw it out!" ... for hours. Their culture is just not compatible with certain modes of thinking, like "safety first". Saving face takes priority in their culture, even if that means kids might die because the drug batch was bad.
- api 3y ago
  Why is it so much cheaper in India or China? Labor cost? No EPA? It has to be so cheap that the cost of offshoring and coordinating all that is dwarfed by the savings.
  - alephnerd 3y ago
    IP Enforcement. If I'm a European, Israeli, or Japanese conglomerate that wants to make a clone of Pfizer or Abbott compounds, I can't do that in the EU or US+Canada because I'd be sued for patent infringement. On the other hand, India, Israel, and Japan don't recognize or enforce American patents for pharmacuticals. After Israel and Japan became developed countries in the 80s-90s, it became expensive to manufacture within both, so the Pharma companies like Teva and Takeda began investing heavily in the Indian Pharma manufacturing base in the Himachal Pradesh-Chandigarh-Haryana-Uttarakhand corridor and the Hyderabad-Pune corridor.
    - unmole 3y ago
      Yeah, no. If what you said was true, The Serum Institute of India wouldn't have licensed the Oxford-AZ vaccine. Same applies for drugs like Molnupiravir where local manufacturers licenced the drug from Merck. Even if these manufacturers were able to get away with patent violations, they still wouldn't be able to export them to the biggest and richest markets.
      - alephnerd 3y ago
        The COVID vaccine was a bad example as it was manufacted on license from AstraZeneca, but the larger Indian market absolutely does this due to how the Indian Patent Act is structured. "Section 3(d) of the Patents Act, 1970, explains that a new form of a known substance, new property / new use for a known substance and the mere use of a known process are not patentable and is not considered distinct from the known substance. Based on this principle, inventions using known substances are not patentable unless, for example, the alleged invention displays a significant increase in efficacy." [0] Ranbaxy, Reddy Labs, and Sun Pharma all started thanks to this loophole, and it has been a massive blocker in any US-India Free Trade Agreement. This is all open knowledge to all players in the India market [1]. It's not necessarily a bad thing btw - it's a major reason India's Pharma and Agrochemical R&D pipeline punches above its weight, but it has an impact on US-India relations, but for other regions such as the EU, Japan, or Developing countries it doesn't have much of an impact. [0] https://www.aipla.org/list/innovate-articles/the-global-significance-of-india-s-pharmaceutical-patent-laws https://www.aipla.org/list/innovate-articles/the-global-sign... [1] https://www.nishithdesai.com/fileadmin/user_upload/pdfs/Patents_and_the_Indian_Pharmaceutical_Industry.pdf https://www.nishithdesai.com/fileadmin/user_upload/pdfs/Pate...
- PaywallBuster 3y ago
  We may need nearshore/onshore QC
  - alephnerd 3y ago
    That's how the FDA operates. That's why the filing above was created by the FDA. You'll have some level of surprise inspections in India, and another set when the batch is imported to the US or EU.
    - delfinom 3y ago
      That is not how the FDA operates. For more than 2 decades, the FDA has basically given these overseas generic factories months of advanced notice of inspections. There are even former inspector who tried to whistleblower over how many times theyve caught those factories fabricating data and other circumstnaces and the FDA just buried the issue. The real question, what in the world changed that made the FDA decide to suddenly cause the effective discontinuation of chemo as a treatment option for the US LOL
  - mwbajor 3y ago
    Its ok to subsidize banks in the US, but we can't subsidize manufacturing (like every other country) for some reason.
    - Slava_Propanei 3y ago
      [dead]
- alephnerd 3y ago
  > Saving face takes priority in their culture To an outsider it looks like saving face, but it really isn't - it's self preservation. Asian business culture doesn't have the concept of "Blameless Post-mortems". If a batch was mismanufactered, the GM at the plant would have heads roll because margins are so low.
- londons_explore 3y ago
  > kids might die because the drug batch was bad. You need to trade that off with 'kids might die because the drug batch was thrown out.' In any supply and demand market, any supplier chucking out product means some buyer somewhere is priced out of the goods they would have bought. If the faulty drugs were even 50% as effective as good drugs, then more lives were probably saved by shipping them. The problem is that there is no way to find those people who would have been priced out and offer them the maybe-50%-effective-maybe-deadly drugs.
  - kneebonian 3y ago
    Is your argument really "we should let people take dangerous and potentially deadly pharmaceuticals to reduce costs." Because I agree that would reduce cost by dropping demand.... Because the people taking them would be dead.
  - salad-tycoon 3y ago
    > If the faulty drugs were even 50% as effective as good drugs, then more lives were probably saved by shipping them. The problem is that there is no way to find those people who would have been priced out and offer them the maybe-50%-effective-maybe-deadly drugs. Huh? You are assuming that they are effective at all and, even worse, let’s assume that it is 50% effective intended drug dose what the hell is in the other 50%?! Does it cause cancer or lead to other disease? Is it innocuous? Frequently contaminants are really not. Look up Chanticleer, Metformin, ranitidine just in the last couple of years. These aren’t expired medications. They are ineffective at an overly generous best and likely dangerous. These also aren’t street dealers where you are okay if 50% is coke and 50% is flour. No pharma company is your friend. They can be useful, sure.
  - HarryHirsch 3y ago
    A bad batch of a drug or precursor does not conform to standards is no good in a safety-critical industry. We are looking at generic drugs, it's not like you have a batch of polyethylene from the pilot plant which does not conform to any standard, and you send it off to SE Asia for use in cheap plastic toys.
- PeterStuer 3y ago
  If by 'their culture' you mean the culture of market capitalism you might be right. What do you think happens to batches of products that exceed certain pollutant treshholds in the US or the EU or anywhere else? They are destroyed? No. They get diluted into other batches until they just meet the tresholds of the allowed percentages.
causality0 3y ago
How do you find out where your bottle of generic pills was made?
- alephnerd 3y ago
  It should have the plant name on the bottle or box itself generally.

crispyambulance 3y ago

There's a lot of details in there related to manufacturing of pharmaceuticals, it's not clear how egregious these irregularities actually are to people that don't know this stuff. So... what does Intas make? What is "an irregularity", what does it mean in plain language? How bad was it there? Is this going to end up as just needing corrective action, or is Intas now barred from selling in the US?

chromatin 3y ago
For perspective, the document indicates their manufacturing area which was supposed to be sterile had bacteria and/or fungus growing on sentinel culture plates.
tobsterius 3y ago
A whole lot of stuff... https://www.accordhealthcare.us/products/ https://www.accordhealthcare.us/products/ (Their main page, https://www.intaspharma.com/products/ https://www.intaspharma.com/products/, links to that URL above for the US-specific market.)
emodendroket 3y ago
I think most people can understand that re-runninf quality checks to fudge the results and destroying records as soon as you realize inspectors have arrived is pretty bad.
HillRat 3y ago
This is pretty indicative of how bad things are: [A] quality control officer ... alleg[ed to investigators] another employee -- upon learning investigators were on the way -- "immediately rushed and tore apart balance printouts along with Auto Titrator spectrums and threw the torn pieces into the small trash container,” which the employee then doused with an acid solution in a bid to “destroy the evidence of tests" with potentially damning results. (https://www.fiercepharma.com/manufacturing/burn-after-reading-fda-blasts-intas-cascade-failures-after-investigators-find-heaps https://www.fiercepharma.com/manufacturing/burn-after-readin...) Intas is under an import alert for most of their drugs, but FDA is allowing twenty-five short-supply drugs (including a lot of chemo drugs) to be imported, which should also tell you how stressed the pharma supply chain is right now.

mhalle 3y ago

Here's another in-depth article on the safety issues surrounding a particular generic for the drug tacrolimus (Prograf is the non-generic drug). https://www.bostonglobe.com/ideas/2019/05/24/ideas-katherine-eban-these-pills-could-kill-you/d4gYXkoMR24n1uoLUkbnqJ/story.html https://www.bostonglobe.com/ideas/2019/05/24/ideas-katherine... https://archive.is/2023.02.27-233237/https://www.bostonglobe.com/ideas/2019/05/24/ideas-katherine-eban-these-pills-could-kill-you/d4gYXkoMR24n1uoLUkbnqJ/story.html https://archive.is/2023.02.27-233237/https://www.bostonglobe...

A_D_E_P_T 3y ago

The FDA's regulatory scheme is absolutely backwards. Investigating foreign facilities and forcing manufacturers to comply with onerous paperwork and recordkeeping details does little or nothing to ensure the availability, quality, and low cost of generic drugs. (In fact, you could argue that it does just the opposite, in reducing availability and increasing cost, with at best indifferent results where drug quality is concerned.) Instead, the FDA should test a statistically valid random sample of any given drug _upon its import and introduction to the US pharmaceutical supply chain._ This would be considerably less expensive for all involved, less demanding and even demeaning for all involved, and of far greater relevance to the quality and safety of the drugs available on the US market.

robg 3y ago
You don’t mention quality controls. What should FDA do if upon said random testing there are concerns? How can they and/or the manufacturer trace the causes without documentation?
- A_D_E_P_T 3y ago
  > What should FDA do if upon said random testing there are concerns? Destroy or return the entire batch, depending on the level of concern. > How can they and/or the manufacturer trace the causes without documentation? That shouldn't be the FDA's concern. The FDA's concern should begin and end with the quality of the actual drugs that are entering the US supply chain. The drugs are things in themselves and can be tested as such -- without regard to where they came from or exactly how they were made.
  - robg 3y ago
    A random sample by definition isn’t the entire batch, so how would you define ‘batch’ without documentation? The FDA would force recall on the entire product entering the country? Until how many samples are cleared?
    - A_D_E_P_T 3y ago

derbOac 3y ago

I don't know why this is allowed to go on. It's been going on for years with almost no consequences. At one point relatively recently they threatened to cut off one generic manufacturer from the US market but then backed off, as far as I remember. They know this is a trend, it's been documented in many articles over the last decade at least. They could make unannounced spot checks, they could do more quality control sampling, they could increase accountability by mandating manufacturing information and links to safety violation records be printed on drug labels. And so forth and so on. Sometimes I feel as if the entire medical industry in the US, and especially the drug regulation culture, has its head in the clouds with either some form of regulatory capture and/or narcissistic feeling of impunity or disregard. Several years ago there was an article in a major news outlet about generics, and how lower income individuals were more likely to to choose brand name drugs over generics. The entire article, with interviews with physicians and medical experts, was framed around this idea that lower income individuals were less educated and didn't understand that generics were "chemically exactly the same" as brand names. This was going on at the same time as all this adulteration and dangerous manufacturing of generics. Not once did they mention that the possibility that maybe lower income individuals had a realistic, healthy fear of being screwed over by inferior products and lack of real oversight from authorities who are supposed to protect them. The entire article was like a snapshot of problems with healthcare in the US: impoverished individuals getting screwed over by credentialed, overprivileged individuals in authority positions who are more concerned about maintaining a fiction of superiority and regulatory capture benefits than actually thinking of protecting the individuals who actually need help. It's like cargo cult medical regulation, but with motivated ignorance. The FDA needs to focus more on safety and quality control and less on the murkier and more questionable topics around efficacy and gatekeeping access.

mwbajor 3y ago
"...Sometimes I feel as if the entire medical industry in the US, and especially the drug regulation culture, has its head in the clouds with either some form of regulatory capture and/or narcissistic feeling of impunity or disregard...." Why is it ok to say this about anything not covid related?
- 3y ago

turtleyacht 3y ago

[PDF]

seatac76 3y ago

This is like the third incident in the last year. Indian government seems to be sleeping at the wheel. ITT the surprise inspection is absolutely a must. The government should step up, the negative consequences for people and industry are very bad.

ghastmaster 3y ago

Why is this redacted. FDA observations should be published in real time so that end users can make judgements and watchdog groups can evaluate and grade companies, batches, and products. That would be a better role for most federal agencies. If states want to make mandates that require adherence to some standard, that is more in line with the original constitutional role of states. I cannot say for certain, but I "feel" that these types of issues crop up quite often and are only publicized when certain corporations do not make the proper lobbying donations to certain people. Limiting the lobbying potential to a state level may prevent my "feeling".

cshimmin 3y ago

Holy smokes... "on 22-Nov-2022, when he came to know that the Investigators are on the walkthrough inspection ofBlock~t> QC laborat01y and are coming in the direction ofbalance room, he immediately rushed and tore apart balanceprintouts along with Auto Titrator spectrums and threw the torn pieces into the small trash container located next to the balance. Later, he threw1<b) < 4) -7 acid solution inside the same trash in an attempt to destroy the evidence ofthe tests that he was working on that had issues with high % RSD and weighing ofmaterial was not in line with the expectation. This trash was removed from the area immediately by your area housekeeper and moved to the QC scrap area. This trash bag was later found hidden under the staircase leading to the fb) < 4>7 floor of your QC laborato1y by another Investigator. No justification was provided upon asking by your QC management for hiding the trash bag."

delfinom 3y ago

I really wonder what triggered this inspection. Generics in the US have been a shitshow for a long time and plenty of whistleblowers from the FDA have come out over how much the FDA heads have buried the issue completely. Personally, this goes back a few years. In high school, we had a quantitative analysis class where we decomposed various brands of acetaminophen pills to measure the % of active ingredient (acetaminophen) and compare to the labeled totals. Pretty every generic brand tested by multiple groups in this lab resulted in contents below 80% of the label. I think the Rite-Aid generic was 60% of the label content. The only one even close was Tylenol coming in at 95%. (With potentially the last 5% being experiment error in recovery since we are talking milligrams and not the most extremely careful lab setup). And that's why I avoid generic acetaminophen if I want it to work LOL

willcipriano 3y ago

But god forbid we reimport drugs from Canada, they might be unsafe you see. Get them from this safe factory in India.