FDA Inspection 952976 — Somalabs, Inc
The FDA completed an inspection of Somalabs, Inc on December 11, 2015 in Northborough, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 11, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Northborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15964 | 21 CFR 111.113(c) | Document - material review, disposition |
| 15992 | 21 CFR 111.127(b) | Quality control operations - packaging; quarantine |