FDA Inspection 1095436 — C.P.M. Contract Pharma GmbH & Co. KG
The FDA completed an inspection of C.P.M. Contract Pharma GmbH & Co. KG on July 5, 2019 in Feldkirchen-Westerham. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 5, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Feldkirchen-Westerham (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |