Company
United StatesBiotek, Inc., Layton, UT – FDA Inspections
Inspection records and compliance data for Biotek, Inc. in Layton, Utah. 2 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected December 20, 2019.
Company Profile
This profile covers Biotek, Inc. based in Layton, Utah, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 1
First inspected August 24, 2017. Last inspected December 20, 2019.
Most cited issue areas
- Component - qualify supplier1 inspection
- Physical plant - proper precautions to prevent mix-ups, contamination1 inspection
- Production, process controls - implement1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 20, 2019 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1113352 |
| August 24, 2017 | OAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1023313 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biotek, Inc.
FEI Number
3001236658
Address
334 Marshall Way Ste F, Layton, Utah 84041, United States
Country
United States
ID: 9990daae-c15e-4ffd-b46e-d6810ba7b258