# FDA 483 - Sovereign Pharmaceuticals, LLC - August 02, 2023

Source: https://www.keypedia.com/records/483/sovereign-pharmaceuticals-llc/c785c674-b957-4593-9617-b2693c60a804

> FDA 483 for Sovereign Pharmaceuticals, LLC on August 02, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sovereign Pharmaceuticals, LLC
- Inspection Date: 2023-08-02
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Sovereign Pharmaceuticals, LLC in Fort Worth, TX, was inspected and cited for significant deficiencies in its quality control unit, laboratory controls, and component testing. The firm failed to properly document deviations and rejected lots during process validation, lacked scientific justification for analytical methods and deviations from test procedures, and did not perform all required tests for incoming raw materials. These issues indicate a lack of robust quality systems and control over drug product manufacturing and testing.

## 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)
- [483 - 2022-04-22](https://www.keypedia.com/records/483/sovereign-pharmaceuticals-llc/02b5f4b2-282c-4d8e-ad0c-71cafad6d140)
- [WARNING_LETTER - 2022-04-22](https://www.keypedia.com/records/warning_letter/sovereign-pharmaceuticals-llc/56437b1f-b184-4771-8dc3-b324b567f1ab)

## Related Officers

- [Rodney L. Tinzie](https://www.keypedia.com/people/rodney-l-tinzie/6f2bba0d-14c2-4eb5-b6a0-ececb5d7d162)
- [Christopher Tran](https://www.keypedia.com/people/christopher-tran/b56e5f0a-d81e-4759-8acd-2c1dd9bebef2)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

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