483
Biomay AGBiomay AG – FDA 483, Jul 27, 2023
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
View Company Profile
ID · 348527f3-6aa4-4dca-b00e-5f06472588a7
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.