FDA Inspection
Somalabs, IncSomalabs, Inc – FDA Inspection, Dec 12, 2018
Record Details
This FDA Inspection record concerns Somalabs, Inc, with an inspection on December 12, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Person
- Joseph T. Frost (Issuing Officer)
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ID · a588c836-68d5-43de-95ca-3461239b006f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1074221
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
11- 21 CFR 111.10(b)(3)Hand washing
- 21 CFR 111.120(e)Quality control operations - quarantine
- 21 CFR 111.15(c)(3)Cleaning compounds and toxic materials - holding
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.27(a)Equipment - design - suitable
- 21 CFR 111.320(a)Examination, testing; appropriate
- 21 CFR 111.503Written procedures - returned dietary supplement; salvaged
- 21 CFR 111.560(b)Quality control, review, approve; investigate, follow-up
- 21 CFR 111.75(a)(2)(ii)(C)Documentation - qualify supplier
- 21 CFR 111.75(c)Specifications met - verify; finished batch
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Other FDA inspections of Somalabs, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2021 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 6, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 11, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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