# FDA 483 - Biomay AG - July 27, 2023

Source: https://www.keypedia.com/records/483/biomay-ag/1474cba3-8eda-4f23-b6a3-36b2ff87e2d7

> FDA 483 for Biomay AG on July 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomay AG
- Inspection Date: 2023-07-27
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of Biomay AG in Vienna, Austria, revealed significant deficiencies in contamination control and equipment qualification. Observations included equipment not in good repair and improper storage of cleaning materials, indicating a failure to follow established procedures. Additionally, the firm failed to perform an adequate air visualization study to qualify critical manufacturing equipment.

## Related Documents

- [483 - 2023-07-27](https://www.keypedia.com/records/483/biomay-ag/348527f3-6aa4-4dca-b00e-5f06472588a7)

Company: https://www.keypedia.com/companies/biomay-ag/163dfb00-c547-4d13-8109-84f7c4a70393

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917