FDA Inspection 940637 — B. Braun Medical, Inc.
The FDA completed an inspection of B. Braun Medical, Inc. on September 21, 2015 in Allentown, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 21, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Allentown, PA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |