Looking at the most recent publication of GMP drug inspection data from CDER, we examine data from FY2018 and evaluate six years’ worth of trends in GMP inspection enforcement.
Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.
FDA is expanding its New Inspection Protocol Project (NIPP) inspection methodology, initially piloted exclusively for sterile drug manufacturing facilities, to include other dosage forms, beginning this month.
Upcoming Webinar: It’s Not All on the Web – Finding the FDA Information You Didn’t Know You Could Have
Join President of FOI Services, Marlene Bobka, for an informative 1-hour webinar about all things FOIA. Gain a deeper understanding of the internal workings of FDA and help prevent legal actions, financial penalties and other costly errors at your company.
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.