FDA Inspection 1012188 — Wyeth Lederle S.R.L
The FDA completed an inspection of Wyeth Lederle S.R.L on Apr 20, 2017 in Catania. 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
- Apr 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Catania (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |