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•Biomay AG•July 27, 2023

FDA 483 - Biomay AG - July 27, 2023

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Record Details

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
Biomay AG
Inspection Date
July 27, 2023
Product Type
Biologics
Office
Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
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ID · 348527f3-6aa4-4dca-b00e-5f06472588a7

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