FDA Inspection 583049 — Bayer Healthcare Manufacturing Srl
The FDA completed an inspection of Bayer Healthcare Manufacturing Srl on Apr 3, 2009 in Garbagnate Milanese. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 3, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Garbagnate Milanese (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |