FDA Inspection 759793 — B.M.P. Bulk Medicines & Pharmaceuticals GmbH
The FDA completed an inspection of B.M.P. Bulk Medicines & Pharmaceuticals GmbH on Nov 16, 2011 in Norderstedt. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 16, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Norderstedt (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |