Company
United StatesBioTE Medical, Irving, TX – FDA Inspections
Inspection records and compliance data for BioTE Medical in Irving, Texas. 3 FDA inspections on record (1 OAI), 2 Form 483s, last inspected April 23, 2018.
Company Profile
This profile covers BioTE Medical based in Irving, Texas, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected November 4, 2016. Last inspected April 23, 2018.
Most cited issue areas
- Failing drug products not rejected1 inspection
- Lack of quality control unit1 inspection
- Procedures to be written and followed1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 23, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1049209 |
| October 6, 2017 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1028940 |
| November 4, 2016 | OAI | Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ | 991397 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BioTE Medical
FEI Number
3012619291
Address
1875 W Walnut Hill Ln Ste 100, Irving, Texas 75038, United States
Country
United States
ID: 5f092a08-f096-45de-9544-a6f92973d87f