FDA Inspection 907061 — Gelpharma S.A. De C.V.
The FDA completed an inspection of Gelpharma S.A. De C.V. on Oct 8, 2014 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: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 8, 2014
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Zapopan (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |