FDA Inspection 1075932 — Laboratorios Sophia, S.A. De C.V.
The FDA completed an inspection of Laboratorios Sophia, S.A. De C.V. on Dec 14, 2018 in Zapopan. 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
- Dec 14, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zapopan (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |