FDA Inspection 1219959 — PenCef Pharma GmbH
The FDA completed an inspection of PenCef Pharma GmbH on Sep 27, 2023 in Berlin. 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 27, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |