# FDA 483 - Sovereign Pharmaceuticals, LLC - April 22, 2022

Source: https://www.keypedia.com/records/483/sovereign-pharmaceuticals-llc/02b5f4b2-282c-4d8e-ad0c-71cafad6d140

> FDA 483 for Sovereign Pharmaceuticals, LLC on April 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sovereign Pharmaceuticals, LLC
- Inspection Date: 2022-04-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Sovereign Pharmaceuticals, LLC, a contract manufacturer in Fort Worth, TX, was cited for significant deficiencies across its quality system, including inadequate written procedures, untimely quality control investigations, and failure to follow complaint handling procedures. Repeat observations highlight issues with uninvestigated validation failures and insufficient laboratory controls, indicating a systemic lack of adherence to established protocols. These issues collectively demonstrate a failure to ensure product quality and compliance with regulatory requirements.

## Related Documents

- [WARNING_LETTER - 2012-02-02](https://www.keypedia.com/records/warning_letter/sovereign-pharmaceuticals-llc/5972dc8a-0e63-4129-b0dd-b2d38e800525)
- [483 - 2019-12-12](https://www.keypedia.com/records/483/sovereign-pharmaceuticals-llc/c999f188-aeb5-47b4-a4fa-dea33076a0c4)
- [483 - 2021-09-01](https://www.keypedia.com/records/483/sovereign-pharmaceuticals-llc/afd44703-d002-4c2f-9ae9-3a19c48695d5)
- [WARNING_LETTER - 2022-04-22](https://www.keypedia.com/records/warning_letter/sovereign-pharmaceuticals-llc/56437b1f-b184-4771-8dc3-b324b567f1ab)
- [483 - 2023-08-02](https://www.keypedia.com/records/483/sovereign-pharmaceuticals-llc/c785c674-b957-4593-9617-b2693c60a804)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Adaris Das Rivera](https://www.keypedia.com/people/adaris-das-rivera/deff94f9-5ef5-4143-98d5-01e0a4e50bbf)
- [Program Coordinator](https://www.keypedia.com/people/martrice-a-packer/e9d89635-6323-4dc7-9222-c44cedcf46c2)

Company: https://www.keypedia.com/companies/sovereign-pharmaceuticals-llc/b8432227-cad1-4c55-91cc-a8c613f765fd

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab