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# Iso-Tex Diagnostics CGMP Issues
- URL: https://www.fdaweb.com/iso-tex-diagnostics-cgmp-issues/
- Published: 2023-08-01T12:00:00.000Z
- Updated: 2026-09-14T18:47:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154994

A 1/30-2/10 FDA inspection at the Iso-Tex Diagnostics drug manufacturing facility in Alvin, TX, found significant violations of current good drug manufacturing (CGMP) regulations for finished drugs. A 7/20 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/iso-tex-diagnostics-inc-655666-07202023?ref=fdaweb.com) says specific violations were:

- failing to have buildings used in the manufacturing, processing, packing, or holding of drug products of a suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations, and failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas, and an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes; and
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

The firm’s responses to the inspection observations were all inadequate, FDA says, noting that similar observations were found in three previous inspections and cited in a 2010 Warning Letter. “You proposed specific remediation for these violations and observations in your responses,” FDA says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA recommends that Iso-Tex engage a qualified consultant to assist it in meeting CGMP requirements. It says the consultant should perform a comprehensive six-system audit of the company’s entire operation for CGMP compliance and evaluate the completion and efficacy of all corrective and preventive actions before Iso-Tex pursues a resolution of its compliance status.

The company was told to correct all violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.