4 ms·

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

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.

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.