483
Bayer HealthCare, LLCFDA 483 - Bayer HealthCare, LLC - August 26, 2022
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An FDA inspection of Bayer HealthCare, LLC in Berkeley, CA, a sterile drug manufacturer, identified three significant issues. The firm failed to follow written procedures for equipment cleaning, inadequately documented deviations from production processes, and lacked proper controls for protective apparel. These observations indicate potential risks to product quality and sterility.
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ID · a5797823-8e9f-4a6d-8cec-13b151299758