3 ms·
The concern should be that they are not in control of their manufacturing. NOT that the flaws discovered are low priority or that the product is low risk or th
by creer 2y ago
The concern should be that they are not in control of their manufacturing.
NOT that the flaws discovered are low priority or that the product is low risk or that they actually do recalls or whatever. The lack of manufacturing control is the actual flaw. And because of lack of control it's pretty likely that an inspection would uncover more problems.
We see this all the time: people point out that a problem is minor, therefore not a big deal.
Or we see a food manufacturer poisoning a bunch of people with product X produced in factory 123. And so inspectors are eventually sent to the shut-down section 123-X (where they uncover a million other problems.) And no inspectors are sent to section 123-Y or 123-Z or any other factory. No tests are performed on other products out in the distribution channel.
That to me is insanity. The uncaught manufacturing problems do not happen out of acts of god, randomly, as some inevitability. They are not caught because management and staff do not care and test and check for them. They are not random instances but likely highly correlated with other problems. Because the root is lack of care and lack of control. In the case of a food or pharma manufacturer caught with their pants down, ANY such instance should be the cause of a major call to order within the company. That one instance is a symptom of lack of management and staff effectiveness. Any lesser reaction should be the call for them getting to the top of the inspection priority list worldwide.
And this very specifically is absurdly insufficient:
> “When there are quality issues identified that could result in harm, patients should rest assured that the FDA does everything within our authority to work with firms to ensure a recall is conducted most effectively,”
Or after inspection at ONE factory:
> “Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,”
How can this NOT be taken as a sign that the other factories are likely also affected?
Which is why for me any such lack of response (company-wide call to arms) results in the company going on the blacklist. ... Which does make shopping difficult.