Company
United StatesIso-Tex Diagnostics, Inc., Alvin, TX – FDA Inspections
Inspection records and compliance data for Iso-Tex Diagnostics, Inc. in Alvin, Texas. 12 FDA inspections on record (4 OAI), 3 Form 483s, 2 warning letters, last inspected February 03, 2026.
Company Profile
This profile covers Iso-Tex Diagnostics, Inc. based in Alvin, Texas, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 4
- VAI
- 3
- NAI
- 5
- Form 483s
- 3
- Warning letters
- 2
First inspected December 10, 2008. Last inspected February 3, 2026.
Most cited issue areas
- Procedures for sterile drug products4 inspections
- Calibration/Inspection/Checking not done3 inspections
- Procedures not in writing, fully followed3 inspections
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 3, 2026 | OAI | Human Drugs · Drug Quality Assurance | 1301096 |
| February 10, 2023 | OAI | Human Drugs · Drug Quality Assurance | 1197186 |
| February 7, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1118892 |
| August 29, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1065390 |
| January 31, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1039153 |
| July 10, 2015 | OAI | Human Drugs · Drug Quality Assurance | 934315 |
| August 27, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 893916 |
| September 27, 2013 | NAI | Human Drugs · Drug Quality Assurance | 850183 |
| September 7, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 797921 |
| September 12, 2011 | VAI | Human Drugs · Drug Quality Assurance | 744287 |
| June 2, 2010 | OAI | Human Drugs · Drug Quality Assurance | 664030 |
| December 10, 2008 | NAI | Human Drugs · Drug Quality Assurance | 551183 |
FDA documents
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Iso-Tex Diagnostics, Inc.
FEI Number
1626310
Address
1511 County Road 129, Alvin, Texas 77511, United States
Country
United States
ID: 59c59676-32cc-4749-b95d-3bdc31559b58