# FDA 483 - Telix IsoTherapeutics Group, Inc. - July 31, 2025

Source: https://www.keypedia.com/records/483/telix-isotherapeutics-group-inc/c0376234-4704-4435-a783-422e3fe06dc2

> FDA 483 for Telix IsoTherapeutics Group, Inc. on July 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Telix IsoTherapeutics Group, Inc.
- Inspection Date: 2025-07-31
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Telix Isotherapeutics Group, Inc. in Angleton, TX, received a Form 483 with 10 observations following an FDA inspection. The findings highlight significant deficiencies in facility maintenance, aseptic processing controls, quality unit responsibilities, and data integrity. These issues indicate a lack of adherence to cGMP requirements, potentially impacting the quality and sterility of drug products.

## Related Documents

- [483 - 2019-05-17](https://www.keypedia.com/records/483/telix-isotherapeutics-group-inc/56a871cf-60da-470d-b931-c45c785a1698)
- [483 - 2025-07-31](https://www.keypedia.com/records/483/telix-isotherapeutics-group-inc/26b52095-1674-4e2c-bd96-0d87ac30a9d9)

## Related Officers

- [Cameron E. Moore](https://www.keypedia.com/people/cameron-e-moore/5a879539-24b7-4c54-99e4-b8e31f18ec9b)
- [Mercedes N. Overton](https://www.keypedia.com/people/mercedes-n-overton/d3c24898-20d4-45f8-adda-24431066c9e6)

Company: https://www.keypedia.com/companies/telix-isotherapeutics-group-inc/4c1ef15c-5396-4f70-9e46-da410d1485cc

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