ARTICLES BY JERRY CHAPMAN
FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis
This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).
FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018
In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.
How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often
The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency.