Company
United StatesTCI Biotech, USA LLC, American Fork, UT – FDA Inspections
Inspection records and compliance data for TCI Biotech, USA LLC in American Fork, Utah. 8 FDA inspections on record, 2 Form 483s, last inspected November 07, 2025.
Company Profile
This profile covers TCI Biotech, USA LLC based in American Fork, Utah, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 5
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 0
First inspected September 30, 2009. Last inspected November 7, 2025.
Most cited issue areas
- All hazards not considered1 inspection
- Approved school1 inspection
- Batch record - complete1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 7, 2025 | VAI | Foods & Cosmetics · Foodborne Biological Hazards | 1290458 |
| November 28, 2022 | VAI | Foods & Cosmetics · Foodborne Biological Hazards | 1191479 |
| March 27, 2017 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1007026 |
| March 27, 2017 | NAI | Foods & Cosmetics, Medical Devices & Rad Health · Foodborne Biological Hazards | 1006561 |
| September 24, 2014 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 896923 |
| December 14, 2011 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 757352 |
| August 30, 2010 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 678217 |
| September 30, 2009 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 615592 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
TCI Biotech, USA LLC
FEI Number
3003969912
Address
737 E 1180 S, American Fork, Utah 84003, United States
Country
United States
ID: f3c375f7-6b1e-4c4e-bad8-401811d50e7a