And yet following the introduction of those paper regulations, the amount of factory contamination fell to near-zero. What a coincidence.
How do you know it fell to zero? Are you personally overseing the testing of all drug batches and ensuring all equipment is calibrated at all times?
In Australia at least, you need to maintain records showing testing of each batch and equipment calibration. Government auditors can come at anytime to review the records, and will shut things down if records are missing/altered/or lacking. Pharmaceutical manufacturers aren't constantly shutting down, so we can assume contamination is fairly low.
Re:Beyond "Abolish the FDA"
by MichaelZuo on Friday December 08, 2023 @11:21AM
(#38570746)
Just because people write a very low or zero value in the records doesn't mean that's actually true for the product that physically is consumed.
At best it can be said to imply what's likely the case in physical reality. But even assuming a very low corruption rate of 0.1%, that's still hundreds of bad record writers putting out bogus records.
You clearly have never participated in an FDA audit as the party under scrutiny.
They look into a lot of things, and their auditors have a lot of experience and know where to look for mistakes.
Their m.o. is to keep digging: if they find something that is not quite right they start asking about who did it, who supervised it, what else that person has worked on... so on and so forth until they find something.
It's pretty terrifying to witness..
> Right now the FDA does this too
Not really. They come and check and confirm your procedures are in line with a bunch of paper standards. In no way they can guarantee the lack of contamination.