FDA Inspection 941214 — Gelcaps Exportadora De Mexico, S.A. De C.V.
The FDA completed an inspection of Gelcaps Exportadora De Mexico, S.A. De C.V. on Sep 8, 2015 in Naucalpan De Juarez. 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). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 8, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Naucalpan De Juarez (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15450 | 21 CFR 111.15(f)(3) | Plumbing - source of contamination |
| 15745 | 21 CFR 111.210(h)(1) | Instructions; specifications; packaged, labeled |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |