FDA Inspection 1006377 — Quimica Y Farmacia S.A. De C.V.
The FDA completed an inspection of Quimica Y Farmacia S.A. De C.V. on Dec 2, 2016 in Ramos Arizpe. 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 2, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ramos Arizpe (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |