FDA 483 - Bayer AG - July 27, 2020

An FDA inspection of Bayer AG, a drug tablet manufacturer in Leverkusen, Germany, revealed significant deficiencies across multiple areas of its operations. The firm was cited for incomplete investigations into microbial excursions and product complaints, as well as a lack of adequate control procedures for manufacturing processes and cleaning validation. Additional observations included insufficient physical separation to prevent cross-contamination, inadequate cleaning procedures, and scientifically unsound laboratory controls for handling out-of-specification results.