FDA 483 - Bayer HealthCare, LLC - November 13, 2019

An FDA inspection of Bayer Healthcare LLC in Berkeley, CA, identified critical deficiencies in quality control and manufacturing processes. These issues included the mislabeling of drug products, leading to a recall and adverse events, as well as inadequate investigation of discrepancies and failures in product testing for foreign materials. The findings highlight a need for improved procedural controls, robust testing methods, and effective document management to ensure product quality and patient safety.