FDA Inspection 700757 — G. Pohl-Boskamp GmbH & Co. KG
The FDA completed an inspection of G. Pohl-Boskamp GmbH & Co. KG on Nov 5, 2010 in Hohenlockstedt. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 5, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hohenlockstedt (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |