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

Source: https://www.keypedia.com/records/483/telix-isotherapeutics-group-inc/26b52095-1674-4e2c-bd96-0d87ac30a9d9

> 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: Dallas District Office
- Summary: Telix Isotherapeutics Group, Inc. in Angleton, TX, was inspected by the FDA, resulting in 10 observations. The inspection revealed significant deficiencies in facility maintenance, aseptic processing controls, quality unit procedures, and data integrity. These issues indicate a lack of adherence to cGMP regulations, potentially impacting the sterility and quality of their drug products and veterinary devices.

## 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/c0376234-4704-4435-a783-422e3fe06dc2)

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

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