FDA Inspection 906747 — Soma Labs Inc.
The FDA completed an inspection of Soma Labs Inc. on December 12, 2014 in Middlesex, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2014
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Middlesex, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15854 | 21 CFR 111.73 | Specifications met - contamination limits |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15964 | 21 CFR 111.113(c) | Document - material review, disposition |
| 16052 | 21 CFR 111.530 | Returned dietary supplement - investigation |