FDA Inspection 948453 — Bayer De Mexico, S.A. De C.V.
The FDA completed an inspection of Bayer De Mexico, S.A. De C.V. on Oct 23, 2015 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
- Oct 23, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lerma (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |