# FDA 483 - Biomay AG - July 27, 2023

Source: https://www.keypedia.com/records/483/biomay-ag/348527f3-6aa4-4dca-b00e-5f06472588a7

> FDA 483 for Biomay AG on July 27, 2023. Product: biologics. 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: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Biomay AG in Vienna, Austria, identified two observations related to manufacturing practices. The firm was cited for not following contamination control procedures, including issues with equipment repair and storage of cleaning supplies. Additionally, the inspection found that equipment was not adequately qualified, specifically lacking an air visualization study for a critical manufacturing area.

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd