FDA Inspection 1109484 — Somalabs, Inc
The FDA completed an inspection of Somalabs, Inc on November 6, 2019 in Northborough, MA. 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
- November 6, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Northborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15847 | 21 CFR 111.73 | Specifications met - component identity |
| 15848 | 21 CFR 111.73 | Specifications met - component purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15960 | 21 CFR 111.113(b)(1) | Quality control - dietary supplement; adulteration |