FDA Inspection 1292536 — B. Braun US Pharmaceutical Manufacturing, LLC
The FDA completed an inspection of B. Braun US Pharmaceutical Manufacturing, LLC on Nov 21, 2025 in Irvine, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 21, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |