FDA Inspection 889209 — Bayer AG
The FDA completed an inspection of Bayer AG on May 13, 2014 in Berlin. 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
- May 13, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |