Two warning letters were issued last week to drug manufacturers. Both cite Quality Unit failures.
Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when resources are limited and staff may have little expertise in these important activities.
In April of 2019, we added 226 483s to our database of 27,500+ FDA inspection documents.
Enforcement this week saw a single untitled letter to a stem cell facility (and 50-plus affiliates) and a warning letter to a compounding pharmacy.
Does the FDA cite the same data integrity keywords on warning letters as 483s? Not really.
This week’s postings included two to drug manufacturers and three to device manufacturers. FDA cites numerous repeat observations from previous inspections.
Part two of this series will walk through our tagging methodologies and analysis on data integrity keyword 483 citations over the last five years.
Enforcement included five warning letters to either homeopathic or OTC firms, continuing the FDA’s focus in this area. Fundamental GMPs seem to be missing.
Did you know that “data integrity” is the second most-cited keyword in CDER warning letters? Or that it ranks 33rd of 483 cited keywords?