1024500
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Xochitepec (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |