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

Source: https://www.keypedia.com/records/483/iso-tex-diagnostics-inc/fd6d304d-4ea8-4067-9a2e-d7f191674ebf

> 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: Dallas District Office
- Summary: Iso-Tex Diagnostics, Inc. in Alvin, TX, a radiopharmaceutical manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern a severe lack of aseptic technique and environmental control in sterile manufacturing, along with inadequate equipment maintenance, calibration, and quality control investigations. These issues indicate a high risk of product contamination and compromise of product sterility.

## 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)
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- [WARNING_LETTER - 2023-02-10](https://www.keypedia.com/records/warning_letter/iso-tex-diagnostics-inc/334e4998-deee-4d28-bfd7-da09eaa4bc1f)

## Related Officers

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9