cpaok,
Everything you do in this industry has to run out of your CGMP (Current Good Manufacturing Practice ) manual.
Normally, at every inspection the regulators do two things, First they review your manuals, looking to see if your have everything covered and approving any modifications you want to make to bring it up to "Current" standards.
Secondly, they then observe your operations to see if your living up to the guidelines set forth in your CGMP manual.
As you see in the warning letter the FDA found that the CGMP Manual is not up to snuff (making scientific decisions for actions), That Pfizer wasn't living up to what is in the manual (inserting sealed bottles in a aseptic zone prior to H2O2 vaporization).
The other item was that PFE didn't follow some standard filings regarding product malfunctions.
Certainly none of this is good, but it certainly isn't the dagger that it could have been.
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