FDA Inspection 1024500 — Schwabe Mexico S.A. De C.V.
The FDA completed an inspection of Schwabe Mexico S.A. De C.V. on Sep 8, 2017 in Xochitepec. 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
- Sep 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 |