BASIC GMP, GMP Enforcement, Quality / CMC Guidance, and More…
Last week, the FDA issued a warning letter after a study drug was administered even though the study had been placed on clinical hold.
In the past week, we added the following 483s to our database of 27,500+ FDA inspection documents. You can obtain 483s, EIRs, InspectorProfiles, and more at the FDAzilla store.
This week the FDA posted 4 new warning letters. One was issued to a cell/tissue product manufacturer, 1 to a firm for failure to list, 1 to a compounding pharmacy, and 1 to a device manufacturer. We cover 3 of these in this post.
From contaminated toothpaste on the shelves to "lack of sterility" across the board, here are last week’s recalls.
In the past week, we added 34 483s to our database of 27,500+ FDA inspection documents.
This was an exceptionally light week of only 2 published warning letters, 1 of which was a compounding pharmacy which we cover in this post.
“It’s an approved device!” “Our raw data are paper.” Data integrity excuses that get the best of us confused. In the finale of this 2-post series, we cover counters to these common objections plus share a helpful MHRA resource.