# FDA 483 - Samson Pharmaceuticals, Inc - March 25, 2016

Source: https://www.globalkeysolutions.net/records/483/samson-pharmaceuticals-inc/d5786061-88a5-4ecf-8308-1ddb88964b69

> FDA 483 for Samson Pharmaceuticals, Inc on March 25, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samson Pharmaceuticals, Inc
- Inspection Date: 2016-03-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Samson Pharmaceuticals, Inc., an OTC drug manufacturer in Commerce, CA, was inspected by the FDA, revealing significant deficiencies. The firm failed to conduct annual product reviews, lacked proper quality control unit authority for product release, and did not routinely verify equipment. Additionally, critical validation records were unavailable, and employee GMP training was insufficient, indicating a broad lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2020-01-29](https://www.globalkeysolutions.net/records/483/samson-pharmaceuticals-inc/6a261834-0d6e-41d0-9499-806127bab329)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

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