FDA Inspection 1029320 — Soma Labs Inc.
The FDA completed an inspection of Soma Labs Inc. on October 20, 2017 in Middlesex, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 20, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Middlesex, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15706 | 21 CFR 111.325(a) | Laboratory operations: electronic |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |