# FDA 483 - Bayer AG - July 27, 2020

Source: https://www.globalkeysolutions.net/records/483/bayer-ag/78f37569-bb65-4bb2-858b-6307d0a03b06

> FDA 483 for Bayer AG on July 27, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bayer AG
- Inspection Date: 2020-07-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Bayer AG, a drug tablet manufacturer in Leverkusen, Germany, revealed significant deficiencies across multiple areas of its operations. The firm was cited for incomplete investigations into microbial excursions and product complaints, as well as a lack of adequate control procedures for manufacturing processes and cleaning validation. Additional observations included insufficient physical separation to prevent cross-contamination, inadequate cleaning procedures, and scientifically unsound laboratory controls for handling out-of-specification results.

## Related Documents

- [483 - 2017-01-20](https://www.globalkeysolutions.net/records/483/bayer-ag/a270ee31-f12b-46d7-a84a-fd3708acd9fc)
- [WARNING_LETTER - 2017-01-20](https://www.globalkeysolutions.net/records/warning_letter/bayer-ag/95954910-8300-48a1-a9ea-e9a9cb4d9ac1)
- [483 - 2019-03-22](https://www.globalkeysolutions.net/records/483/bayer-ag/9e84a5c7-4f9e-40e6-8562-b1ae8d632e50)

## Related Officers

- [Wayne D. Mcgrath](https://www.globalkeysolutions.net/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

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