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

Source: https://www.keypedia.com/records/warning_letter/sovereign-pharmaceuticals-llc/56437b1f-b184-4771-8dc3-b324b567f1ab

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sovereign Pharmaceuticals, LLC
- Inspection Date: 2022-04-22
- Product Type: Drugs
- Office Name: Office of Pharmaceutical Quality Operations Division I
- Summary: The FDA issued a Warning Letter to Sovereign Pharmaceuticals, LLC, following an inspection from April 13-22, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The company manufactures bulk tablets for (b)(4), which are unapproved drugs and biological products.

Key violations include:
1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes for bulk (b)(4) tablets, with multiple out-of-specification (OOS) results for active ingredients, tablet assay, and weight during process performance qualification (PPQ). The company's response was deemed inadequate, lacking sufficient data to show process variability and an ongoing program for monitoring process control.
2. **Failure to thoroughly investigate unexplained discrepancies or batch failures (21 CFR 211.192):** Approximately 27 validation and commercial batches of (b)(4) tablets with OOS blend powder drum assay results were compressed and released without adequate investigation. The firm's investigation was deficient, not extending to all similarly impacted products and failing to assess other sources of variability.
3. **Failure of the quality control unit to establish and follow written procedures (21 CFR 211.22(d)):** The Quality Unit (QU) failed to adequately

## 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)
- [483 - 2023-08-02](https://www.keypedia.com/records/483/sovereign-pharmaceuticals-llc/c785c674-b957-4593-9617-b2693c60a804)

## Related Officers

- [Director of Investigations Branch](https://www.keypedia.com/people/tamala-p-bogan/af87cd07-1e38-459f-94a0-58b5bf5f533c)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations-division-i/798d6a62-d1f1-4f7c-8de3-465e277c13da