Sourcebrook / Guides
Guides to FDA inspection records
What FDA's inspection outcomes mean, where they are published, and what the records show, from the data behind Sourcebrook.
- NAI, VAI and OAI: what FDA's inspection classifications meanThe three outcomes of an FDA inspection, and how often each was given in 66,781 drug and biologics inspections since October 2008, by year and by country.
- FDA Form 483: what it is and where to find oneWhat follows a 483, how it differs from an OAI and a warning letter, the regulations cited most, and 273 483s reported in SEC filings.
- FDA inspection records of major CDMOsSites, inspections and every OAI for 30 contract manufacturers, including Catalent, Lonza, Patheon and WuXi.