FDA Inspection 1101920 — Bayer Weimar GmbH Und Co. KG
The FDA completed an inspection of Bayer Weimar GmbH Und Co. KG on Sep 13, 2019 in Weimar. 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 13, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Weimar (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |