FDA Inspection 1102816 — Bayer AG
The FDA completed an inspection of Bayer AG on Sep 24, 2019 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 24, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |