Company
United StatesCoretex Products Inc., Erwin, TN – FDA Inspections
Inspection records and compliance data for Coretex Products Inc. in Erwin, Tennessee. 3 FDA inspections on record, 1 Form 483, last inspected February 25, 2026.
Company Profile
This profile covers Coretex Products Inc. based in Erwin, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 2, 2015. Last inspected February 25, 2026.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Cleaning / Sanitizing / Maintenance1 inspection
- Defined areas of adequate size for operations1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 25, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1304456 |
| April 28, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1140945 |
| November 2, 2015 | VAI | Human Drugs · Drug Quality Assurance | 946394 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Coretex Products Inc.
FEI Number
3002719565
Address
1311 N Main Ave, Erwin, Tennessee 37650, United States
Country
United States
ID: 87a5052d-fa58-4a3b-a539-e370f53b05bf