# FDA 483 - Stason Pharmaceuticals, Inc. - October 25, 2019

Source: https://www.keypedia.com/records/483/stason-pharmaceuticals-inc/e31d5405-fa3f-4f2f-ad64-89a8b7b613b6

> FDA 483 for Stason Pharmaceuticals, Inc. on October 25, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Stason Pharmaceuticals, Inc.
- Inspection Date: 2019-10-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Stason Pharmaceuticals, Inc. in Irvine, CA, revealed significant deficiencies in manufacturing and quality control processes. The firm failed to ensure proper drug product testing, stability data, and thorough investigations into out-of-specification results and complaints. Issues also included inadequate contamination control, improper gowning, and compromised data integrity in laboratory systems.

## Related Documents

- [WARNING_LETTER - 2019-10-25](https://www.keypedia.com/records/warning_letter/stason-pharmaceuticals-inc/785e47c0-b5ba-4ef1-8e59-3453b4f044e1)
- [483 - 2021-04-13](https://www.keypedia.com/records/483/stason-pharmaceuticals-inc/9806ac15-ac99-4c40-948b-486265e6ae4d)

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.keypedia.com/companies/stason-pharmaceuticals-inc/f8669d38-d60b-4f0c-856a-ac536c422fae

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6