FDA Inspection 1252695 — B. Braun US Pharmaceutical Manufacturing LLC
The FDA completed an inspection of B. Braun US Pharmaceutical Manufacturing LLC on Jan 31, 2025 in Daytona Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Daytona Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |