Summary
cGMP inspections by FDA and EMEA. FDA inspection was definitely inferior.
Analysis
Recently, my consulting client has been inspected for cGMP compliance by both FDA and EMEA. The quality of the inspectors and the findings by FDA were of much lower quality than those of the European Union (EMEA). Although additional resources do not necessarily equate with better inspections, it is imperative that FDA improve the level of both personnel and inspections to help safeguard the quality of both food and medical products.
This author consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
