FDA Inspection 1051655 — Bayer De Mexico, S.A. De C.V.
The FDA completed an inspection of Bayer De Mexico, S.A. De C.V. on May 11, 2018 in Lerma. 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
- May 11, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lerma (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3631 | 21 CFR 211.170(b) | Investigation of reserve sample deterioration |