FDA Inspection 1101920 — Bayer Weimar GmbH und Co. KG
The FDA completed an inspection of Bayer Weimar GmbH und Co. KG on September 13, 2019 in Weimar. 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
- September 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 |