Loading…
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.