FDA Inspection 1125538 — Bayer AG
The FDA completed an inspection of Bayer AG on Jul 27, 2020 in Leverkusen. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 27, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Leverkusen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |