Iso-Tex Diagnostics, Inc.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 1511 County Road 129, Alvin, Texas (TX) 77511, United States (USA)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 1626310 · DUNS 181202995
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 2 drugs. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2026-02-03
- OAIDrug Quality Assurance2023-02-10
- NAIDrug Quality Assurance2020-02-07
- NAIBioresearch Monitoring2018-08-29
- VAIDrug Quality Assurance2018-01-31
- OAIDrug Quality Assurance2015-07-10
- OAIUnapproved and Misbranded Drugs2015-07-10
- NAIBioresearch Monitoring2014-08-27
- NAIDrug Quality Assurance2013-09-27
- VAIBioresearch Monitoring2012-09-07
- VAIDrug Quality Assurance2011-09-12
- OAIDrug Quality Assurance2010-06-02
- NAIDrug Quality Assurance2008-12-10
Drugs this plant is listed as making
2 distinct drugs across 3 products name this site in their FDA label.
- Iodinated I-131 AlbuminIso-Tex Diagnostics, Inc.
- Sodium Iothalamate I-125 injectionIso-Tex Diagnostics, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.