# FDA 483 - Stason Pharmaceuticals, Inc. - April 13, 2021

Source: https://www.globalkeysolutions.net/records/483/stason-pharmaceuticals-inc/9806ac15-ac99-4c40-948b-486265e6ae4d

> FDA 483 for Stason Pharmaceuticals, Inc. on April 13, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stason Pharmaceuticals, Inc.
- Inspection Date: 2021-04-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Stason Pharmaceuticals, Inc. in Irvine, CA, revealed two significant observations related to quality system deficiencies. The firm was cited for inadequate employee training, specifically failing to provide follow-up training after identifying a trend of human errors. Additionally, the quality control unit lacked written procedures, particularly concerning the evaluation and assessment of an outside contract lab used for microbiological testing.

## Related Documents

- [483 - 2019-10-25](https://www.globalkeysolutions.net/records/483/stason-pharmaceuticals-inc/e31d5405-fa3f-4f2f-ad64-89a8b7b613b6)
- [WARNING_LETTER - 2019-10-25](https://www.globalkeysolutions.net/records/warning_letter/stason-pharmaceuticals-inc/785e47c0-b5ba-4ef1-8e59-3453b4f044e1)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

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

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