FDA 483 - Bayer AG - March 22, 2019

Bayer Pharma AG in Leverkusen, Germany, was inspected and cited for multiple deficiencies in its manufacturing and control processes. Observations included inadequate laboratory control mechanisms, improper storage of labeling materials, insufficient cleaning and maintenance procedures, and incomplete batch production records. The firm also failed to establish adequate control procedures for manufacturing processes and properly identify production areas and equipment.