There were six warning letter postings during this week, including one regarding Akorn’s site in Somerset, NJ that the company announced a few weeks ago.
GMP expert Barbara W. Unger provides her assessment of CDER’s State of Pharmaceutical Quality Report.
A surprisingly busy week for enforcement considering the federal holiday. Warning letter enforcement includes five drug warning letters published this week, two of which were sent to API re-packagers, and one to a compounding pharmacy.
Three warning letters were posted this week in the areas we cover: two for drugs and one for device GMP violations. Akorn also announced that they received a warning letter but it has not yet been published.
Unlike last week, warning letter enforcement is sparse this week with only one drug GMP warning letter, none to compounding pharmacies and none to device firms.
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.