FDA Inspection 812623 — Soma Labs Inc.
The FDA completed an inspection of Soma Labs Inc. on January 17, 2013 in Middlesex, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 17, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Middlesex, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15727 | 21 CFR 111.365(e) | Microorganism, decomposition - remove, destroy, prevent |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15778 | 21 CFR 111.415(b) | Dietary supplement - protect, contamination |
| 15867 | 21 CFR 111.75(b)(1) | Specifications met, in-process - quality finished batch |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |