# FDA 483 - Iso-Tex Diagnostics, Inc. - February 10, 2023

Source: https://www.keypedia.com/records/483/iso-tex-diagnostics-inc/c1992dd5-73f0-447d-a773-3e3a63cddc38

> FDA 483 for Iso-Tex Diagnostics, Inc. on February 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Iso-Tex Diagnostics, Inc.
- Inspection Date: 2023-02-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Iso-Tex Diagnostics, Inc., a radiopharmaceutical manufacturer in Alvin, TX, was cited for significant deficiencies during an FDA inspection. The observations primarily concern poor aseptic processing practices, inadequate environmental monitoring, and facility design issues that compromise sterility. These issues indicate a serious lack of control over the manufacturing environment and processes for sterile drug products.

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

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-fields/066519e8-20eb-4c41-aaf6-5b17348a0409)
- [Microbiologist](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

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