FDA Inspection 1074221 — Somalabs, Inc
The FDA completed an inspection of Somalabs, Inc on December 12, 2018 in Northborough, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 12, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Northborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15391 | 21 CFR 111.10(b)(3) | Hand washing |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 16044 | 21 CFR 111.503 | Written procedures - returned dietary supplement; salvaged |