# FDA 483 - Petscript Inc. - September 18, 2025

Source: https://www.keypedia.com/records/483/petscript-inc/396b26fb-d6fc-44e9-a6c3-52ac826e50bf

> FDA 483 for Petscript Inc. on September 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Petscript Inc.
- Inspection Date: 2025-09-18
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Petscript Inc. in Paris, TX, a producer of sterile and non-sterile drug products, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight a severe lack of written procedures, inadequate validation of aseptic and sterilization processes, insufficient environmental and personnel monitoring, and a complete absence of routine sterility, endotoxin, and potency testing for drug products. The firm also failed to establish a stability testing program and maintain complete batch records, indicating widespread quality control and manufacturing process failures.

## Related Officers

- [Katherine M. Breed](https://www.keypedia.com/people/katherine-m-breed/d4f9d988-f274-4a06-b3b5-967e9471e707)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/petscript-inc/bdea30f2-36fe-4898-b328-73992e75579b

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