# FDA 483 - Samson Pharmaceuticals, Inc - January 29, 2020

Source: https://www.globalkeysolutions.net/records/483/samson-pharmaceuticals-inc/6a261834-0d6e-41d0-9499-806127bab329

> FDA 483 for Samson Pharmaceuticals, Inc on January 29, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Samson Pharmaceuticals, Inc
- Inspection Date: 2020-01-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Samsan Pharmaceuticals, Inc. in Commerce, CA, revealed significant deficiencies across multiple systems, particularly concerning the manufacturing of Pure Eyes sterile eye drops. The firm failed to maintain adequate quality control, ensure aseptic processing integrity, and properly manage stability testing and component identification. These issues indicate a serious lack of adherence to good manufacturing practices for sterile drug products.

## Related Documents

- [483 - 2016-03-25](https://www.globalkeysolutions.net/records/483/samson-pharmaceuticals-inc/d5786061-88a5-4ecf-8308-1ddb88964b69)

## Related Officers

- [https://www.fda.gov/media/120628/download](https://www.globalkeysolutions.net/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

Company: https://www.globalkeysolutions.net/companies/samson-pharmaceuticals-inc/4250f533-840c-44d3-a3e7-cc538c63ca03

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