Iso-Tex Diagnostics, Inc.
FDA inspection history across 2 sites, 2001 to 2023
- 4
- Warning letters
- 2
- Form 483s
Every document, by year
- Warning letter
- Form 483
2001: one warning letter; 2010: one warning letter; 2015: one warning letter; 2018: one Form 483; 2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001One warning letter, at Friendswood, Texas.
- 2010One warning letter, at Friendswood, Texas.
- 2015One warning letter, at Friendswood, Texas.
- 2018One Form 483, at Alvin, Texas.
- 2023One warning letter and one Form 483, at Alvin, Texas.
- 2023The longest 483 on file: 7 observations over 7 pages at Alvin, Texas.
Cited most
Across all Iso-Tex Diagnostics observations on file
- 21 CFR 211.42(a)Design and construction features4
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(b)(4)General requirements1
- 21 CFR 211.52Washing and toilet facilities1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Iso-Tex Diagnostics file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Alvin, Texas
Two Form 483s and one warning letter · 2018 to 2023 · 8 observations
Latest: Warning letter, Jul 20, 2023 →Friendswood, Texas
Three warning letters · 2001 to 2015
Latest: Warning letter, Mar 2, 2015 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-20 | Warning letter Warning letter | Alvin, Texas | — | $99 |
| 2023-02-10 | 483 Form 483 | Alvin, Texas | 7 | $99 |
| 2018-01-31 | 483 Form 483 | Alvin, Texas | 1 | $99 |
| 2015-03-02 | Warning letter Warning letter | Friendswood, Texas | — | $99 |
| 2010-12-03 | Warning letter Warning letter | Friendswood, Texas | — | $99 |
| 2001-11-08 | Warning letter Warning letter | Friendswood, Texas | — | $99 |
Investigators on these documents
Camerson E. Moore (1)Christopher N. Tran (1)Patty P. Kaewussdangkul (1)
FEI number 1626310 · most recent document Jul 20, 2023
About Iso-Tex Diagnostics, Inc.
How many FDA Form 483s has Iso-Tex Diagnostics, Inc. received?
FDA Intel has 2 Form 483s on file for Iso-Tex Diagnostics, Inc.; the most recent is dated Feb 10, 2023.
When was Iso-Tex Diagnostics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Iso-Tex Diagnostics, Inc. is a Form 483 dated Feb 10, 2023, for the site in Alvin, Texas.
What did FDA cite at Iso-Tex Diagnostics, Inc.?
The regulations cited most in the observations on file for Iso-Tex Diagnostics, Inc. are 21 CFR 211.42(a) (Design and construction features), 4 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.160(b)(4) (General requirements), 1 time.
Has Iso-Tex Diagnostics, Inc. received an FDA warning letter?
Yes. FDA Intel has 4 FDA warning letters on file for Iso-Tex Diagnostics, Inc.; the most recent is dated Jul 20, 2023.