FDA Inspection
TCI Biotech, USA LLCTCI Biotech, USA LLC – FDA Inspection, Mar 27, 2017
Record Details
This FDA Inspection record concerns TCI Biotech, USA LLC, with an inspection on March 27, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · a15aa845-5305-43cc-a8e2-fd07bc741c8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007026
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(b)(1)Master manufacturing record - specifications; quality
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 7, 2025 | VAI | Denver District Office | Foodborne Biological Hazards |
| November 28, 2022 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| 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 1290458 - 2025-11-07
- FDA Inspection 1191479 - 2022-11-28
- FDA Inspection 1006561 - 2017-03-27
- FDA Inspection 896923 - 2014-09-24
- FDA Inspection 757352 - 2011-12-14
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