FDA Inspection
Burgwedel Biotech GmbHBurgwedel Biotech GmbH – FDA Inspection, Aug 29, 2023
Record Details
This FDA Inspection record concerns Burgwedel Biotech GmbH, with an inspection on August 29, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 79630452-6b2f-41ae-bbea-574bf16cf924
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216178
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(a)Deviations from laboratory control requirements
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Other FDA inspections of Burgwedel Biotech GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2026 | Not classified | Office of Inspections and Investigations | Vaccines and Allergenic Products |
| February 26, 2019 | Not classified | Office of Inspections and Investigations |
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