FDA Inspection 1009384 — C.P.M. Contract Pharma GmbH & Co. KG
The FDA completed an inspection of C.P.M. Contract Pharma GmbH & Co. KG on April 7, 2017 in Feldkirchen-Westerham. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Feldkirchen-Westerham (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |