# FDA 483 - Bayer AG - March 22, 2019

Source: https://www.globalkeysolutions.net/records/483/bayer-ag/9e84a5c7-4f9e-40e6-8562-b1ae8d632e50

> FDA 483 for Bayer AG on March 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bayer AG
- Inspection Date: 2019-03-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

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- [WARNING_LETTER - 2017-01-20](https://www.globalkeysolutions.net/records/warning_letter/bayer-ag/95954910-8300-48a1-a9ea-e9a9cb4d9ac1)
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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)
- [Consumer Safety Officer (Drug Specialist)](https://www.globalkeysolutions.net/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

Company: https://www.globalkeysolutions.net/companies/bayer-ag/c999165f-4c13-4f49-b979-087064975cb0

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1