FDA Inspection
B. Braun US Pharmaceutical Manufacturing LLCB. Braun US Pharmaceutical Manufacturing LLC – FDA Inspection, Jan 31, 2025
Record Details
This FDA Inspection record concerns B. Braun US Pharmaceutical Manufacturing LLC, with an inspection on January 31, 2025, issued by the Florida District Office, covering human drugs.
- Inspection Date
- January 31, 2025
- Product Type
- Human Drugs
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ID · a0771673-961f-4023-b5db-d3973774cf6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1252695
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.110(b)In-process conformity - examination, sample testing
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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 |
| November 22, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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