# FDA 483 - Telix IsoTherapeutics Group, Inc. - May 17, 2019

Source: https://www.keypedia.com/records/483/telix-isotherapeutics-group-inc/56a871cf-60da-470d-b931-c45c785a1698

> FDA 483 for Telix IsoTherapeutics Group, Inc. on May 17, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Telix IsoTherapeutics Group, Inc.
- Inspection Date: 2019-05-17
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Isotherapeutics Group LLC in Angleton, TX, revealed significant deficiencies in current Good Manufacturing Practices for drug products. The firm was cited for inadequate cleanroom design and maintenance, insufficient equipment cleaning and sanitization procedures, and failures in their quality control unit. These issues included a lack of written procedures for production records, complaint handling, and labeling, indicating a lack of control over critical manufacturing processes.

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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