FDA Inspection
Burgwedel Biotech GmbHBurgwedel Biotech GmbH – FDA Inspection, Aug 7, 2026
Record Details
This FDA Inspection record concerns Burgwedel Biotech GmbH, with an inspection on August 7, 2026, issued by the Office of Inspections and Investigations, covering biologics.
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ID · 24f836b9-608e-40fa-85c2-e4e524a21807
Inspection Facts
- Inspection number
- 1332374
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
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Other FDA inspections of Burgwedel Biotech GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2023 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 26, 2019 | Not classified | Office of Inspections and Investigations |
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