FDA Inspection
TCI Biotech, USA LLCTCI Biotech, USA LLC – FDA Inspection, Nov 7, 2025
Record Details
This FDA Inspection record concerns TCI Biotech, USA LLC, with an inspection on November 7, 2025, issued by the Denver District Office, covering foods & cosmetics.
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ID · c8edd78b-f009-4bd5-b340-215ab5310cbc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1290458
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 108.25(f)Approved school
- 21 CFR 111.260Batch record - required information
- 21 CFR 111.210Master manufacturing record - record requirements
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 120.8(a)HACCP plan not implemented
- 21 CFR 120.7(c)All hazards not considered
- 21 CFR 111.70(b)Specifications - components
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TCI Biotech, USA LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 28, 2022 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| March 27, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 27, 2017 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 24, 2014 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 14, 2011 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for TCI Biotech, USA LLC
- FDA Inspection 1191479 - 2022-11-28
- FDA Inspection 1007026 - 2017-03-27
- FDA Inspection 1006561 - 2017-03-27
- FDA Inspection 896923 - 2014-09-24
- FDA Inspection 757352 - 2011-12-14
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