FDA EIR - Sovereign Pharmaceuticals, LLC - November 10, 2016

Sovereign Pharmaceuticals, LLC underwent an FDA inspection from November 7-10, 2016, at its Fort Worth, TX facility, focusing on human drug manufacturing. Conducted under FDA Compliance Programs for abbreviated drug process inspection and drug quality reporting, the review concluded with a four-item Form FDA 483, identifying significant issues related to Current Good Manufacturing Practice (CGMP).

Main violations included inadequate facility construction and cleaning, specifically dirty air ducts and vents in manufacturing areas, posing a contamination risk (21 CFR 211.42(a)). Employees failed to wear required mouth/nose covers during bulk blending operations, raising concerns about product protection (21 CFR 211.113(a)). The firm also lacked distinctive labeling for incoming Active Pharmaceutical Ingredients in the warehouse, impeding traceability and status identification (21 CFR 211.80(d)). Furthermore, the Quality Control Unit lacked written procedures for managing electronic data, including organizing HPLC project folders, defining user access levels, and establishing audit trail policies for the HPLC system (21 CFR 211.22(d)).

Management, led by the President and CEO, acknowledged the observations, committing to implement corrections and provide a written response within 15 business days. The FDA investigator underscored the potential for further regulatory action, such as product seizure or injunction, if non-compliance persists.