FDA Inspection
Uniwell Laboratories, LLCUniwell Laboratories, LLC – FDA Inspection, Sep 25, 2025
Record Details
This FDA Inspection record concerns Uniwell Laboratories, LLC, with an inspection on September 25, 2025, issued by the Dallas District Office, covering foods & cosmetics.
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ID · ee1c0392-7aba-4153-b085-fcf0a99460d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1252706
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.75(c)Specifications met - verify; finished batch
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Other FDA inspections of Uniwell Laboratories, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 4, 2015 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Uniwell Laboratories, LLC
- FDA Inspection 1158182 - 2021-11-17
- FDA Inspection 929899 - 2015-05-04
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