FDA Inspection 1192366 — Bayer De Mexico, S.A. De C.V.
The FDA completed an inspection of Bayer De Mexico, S.A. De C.V. on Dec 9, 2022 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 9, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lerma (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |