FDA Inspection 1005806 — Gelpharma S.A. De C.V.
The FDA completed an inspection of Gelpharma S.A. De C.V. on Dec 9, 2016 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 9, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zapopan (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |