FDA Inspection 756383 — Soma Labs Inc.
The FDA completed an inspection of Soma Labs Inc. on December 2, 2011 in Middlesex, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Middlesex, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15528 | 21 CFR 111.30(d) | Equipment - automated - controls, process changes |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15951 | 21 CFR 111.110(c) | Quality control operations - tests, examinations; results |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 16038 | 21 CFR 111.605(b) | Records - original, true copies |