# FDA 483 - Iso-Tex Diagnostics, Inc. - February 03, 2026

Source: https://www.keypedia.com/records/483/iso-tex-diagnostics-inc/487d066e-4e63-44a6-8e0b-040f047cddd3

> FDA 483 for Iso-Tex Diagnostics, Inc. on February 03, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Iso-Tex Diagnostics, Inc.
- Inspection Date: 2026-02-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Iso-Tex Diagnostics, Inc. in Alvin, TX, a radiopharmaceutical manufacturer, revealed significant deficiencies in aseptic processing, facility maintenance, equipment calibration, and quality control unit responsibilities. Repeat observations highlight persistent issues with preventing microbial contamination and ensuring proper equipment performance, indicating a high severity of non-compliance. The firm failed to follow procedures for sterile drug product manufacturing and adequately investigate sterility failures.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/iso-tex-diagnostics-inc/a7177599-1b5a-4dc5-a787-2c5469984d7c)
- [483 - 2018-01-31](https://www.keypedia.com/records/483/iso-tex-diagnostics-inc/540c0280-7b11-4bde-98a4-d92afe29fa0e)
- [483 - 2023-02-10](https://www.keypedia.com/records/483/iso-tex-diagnostics-inc/c1992dd5-73f0-447d-a773-3e3a63cddc38)
- [483 - 2023-02-10](https://www.keypedia.com/records/483/iso-tex-diagnostics-inc/f7a6d00c-9751-4ee5-8914-4ba120cea0f2)
- [WARNING_LETTER - 2023-02-10](https://www.keypedia.com/records/warning_letter/iso-tex-diagnostics-inc/334e4998-deee-4d28-bfd7-da09eaa4bc1f)

## Related Officers

- [Cameron E. Moore](https://www.keypedia.com/people/cameron-e-moore/5a879539-24b7-4c54-99e4-b8e31f18ec9b)
- [Rodney L. Tizzle](https://www.keypedia.com/people/rodney-l-tizzle/6cd74272-6213-43c4-b030-91983e94ee5d)
- [Oluwasefunm Agbanigo](https://www.keypedia.com/people/oluwasefunm-agbanigo/a25367a6-c32e-4706-9299-e90a15da2e95)

Company: https://www.keypedia.com/companies/iso-tex-diagnostics-inc/59c59676-32cc-4749-b95d-3bdc31559b58

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab