FDA Inspection 1057639 — B. Braun US Pharmaceutical Manufacturing, LLC
The FDA completed an inspection of B. Braun US Pharmaceutical Manufacturing, LLC on June 29, 2018 in Irvine, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 29, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2397 | 21 CFR 211.194(a)(1) | Description and Identification of Samples |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |