Sovereign Pharmaceuticals, LLC – FDA EIR, Jan 8, 2016

An FDA inspection of Sovereign Pharmaceuticals, LLC, a human drug manufacturer in Fort Worth, TX, occurred from January 5-8, 2016. Conducted under current good manufacturing practice (CGMP) regulations, the inspection revealed three significant deviations documented in an FDA Form 483. The first observation cited inadequate laboratory controls, specifically concerning product testing for content uniformity. For Clindamycin Palmitate Hydrochloride for Oral Solution, initial testing (Level I) yielded out-of-specification results. Instead of proceeding with the mandated follow-up Level II testing as per USP guidelines, the firm initiated an internal investigation and reported passing retest results using an altered sample preparation, indicating a departure from scientifically sound procedures to ensure drug quality and purity. Secondly, equipment maintenance was insufficient. A mixer displayed chipped paint and visible residue in areas challenging to clean, presenting a risk of product contamination. The associated cleaning procedures also lacked specific instructions for these problematic sections of the equipment. Finally, the facility's design for processing areas was found unsuitable. The raw material sampling room's ventilation system allowed unconditioned air to enter near the floor, failing to adequately protect open raw material containers from potential contaminants. Dr. Miles B. Davis, President and CEO, acknowledged these findings and committed to implementing corrective actions. Sovereign Pharmaceuticals, LLC, is required to submit a detailed written response to the FDA within 15 business days.