FDA Inspection
B. Braun US Pharmaceutical Manufacturing LLCB. Braun US Pharmaceutical Manufacturing LLC – FDA Inspection, Nov 22, 2022
Record Details
This FDA Inspection record concerns B. Braun US Pharmaceutical Manufacturing LLC, with an inspection on November 22, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 22, 2022
- Product Type
- Drugs
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ID · 1827eab1-4df0-4b57-a72d-5544549c281d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1191429
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of B. Braun US Pharmaceutical Manufacturing LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 25, 2026 | Not classified | Florida District Office | Drug Quality Assurance |
| January 31, 2025 | VAI | Florida District Office | Drug Quality Assurance |
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