FDA EIR - Bayer AG - March 22, 2019

An FDA for-cause and general Good Manufacturing Practices (GMP) inspection of Bayer Pharma AG, located in Leverkusen, Germany, was conducted from March 11 to March 22, 2019. This inspection followed a previous "Official Action Indicated" (OAI) classification in 2017, which resulted in an 11-item Form FDA 483. Since the last inspection, Bayer Pharma AG has discontinued supplying sterile and extended-release products to the U.S. market, now focusing solely on immediate-release solid dose, non-sterile finished forms and active pharmaceutical ingredient processing. During the current inspection, which covered Quality, Materials, Laboratory Control, Facilities and Equipment, and Production Systems, some corrections from the prior inspection were acknowledged. However, the inspection concluded with the issuance of a six-item Form FDA 483 to the Executive Vice President. The observations included failures such as not following established laboratory mechanisms, improper storage of labels, insufficient detail in cleaning and maintenance procedures, inadequate control procedures to monitor variability, incomplete batch production and control records, and unidentified processing lines and major equipment. These violations fall under the regulatory framework of the U.S. Federal Food, Drug, and Cosmetic Act. Management committed to undertaking corrective actions and providing a written response within 15 business days.