FDA Inspection 614261 — Omnilife Manufactura S.A. de C.V.
The FDA completed an inspection of Omnilife Manufactura S.A. de C.V. on August 31, 2009 in Tlaquepaque. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 31, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Tlaquepaque (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 15508 | 21 CFR 111.27(a)(5)(ii) | Refrigerator, freezer - alarm |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15675 | 21 CFR 111.315(b) | Sampling plans; establish, follow |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |