Mr. Paul D. Hafey
President
Sovereign Pharmaceuticals, LLC
7590 Sand Street
Fort Worth , TX 76118
United StatesFEI 3003229412Issued Oct 5, 2022Office of Pharmaceutical Quality Operations, Division II
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003229412.
Violations6
Issue DateOct 5, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Sovereign Pharmaceuticals, LLC
Location
Mr. Paul D. Hafey
President
Sovereign Pharmaceuticals, LLC
7590 Sand Street
Fort Worth , TX 76118
United States
FEI Number
3003229412
Country
United States
Issue Date
October 05, 2022
Issuing Office
Office of Pharmaceutical Quality Operations, Division II
Product Type
Drugs
Status
Open
Summary
Sovereign Pharmaceuticals, LLC was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drug products, including biological products containing proteins intended to treat diseases or conditions. FDA inspectors found that the company's manufacturing methods, facilities, and controls did not conform to CGMP regulations, rendering the drug products adulterated under federal law. Additionally, the company failed to properly list itself as a manufacturer in drug listing submissions as required by FDA regulations, creating regulatory documentation deficiencies.
Sovereign Pharmaceuticals, LLC FDA Warning Letter, October 5, 2022
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