FDA Inspection 1226163 — B. Braun US Pharmaceutical Manufacturing, LLC
The FDA completed an inspection of B. Braun US Pharmaceutical Manufacturing, LLC on Dec 15, 2023 in Irvine, CA. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1956 | 21 CFR 211.180(e)(1) | Representative Number of Batches for Annual Review |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |