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Former FDA Investigator Peter Baker gives insight to MHRA's GXP guide for data integrity.
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This was a busy week in contrast to the past two weeks in terms of posted warning letters. Seven drug warning letters and one device warning letter were posted.
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.
Two warning letters were issued last week to drug manufacturers. Both cite Quality Unit failures.
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.