FDA Cites Sovereign Pharmaceuticals for Building Failures

Sovereign Pharmaceuticals’ Texas facility received a Form 483 after an inspection in November found numerous problems in the facility, including the building’s construction.

FDA inspectors cited the firm for wall vents that were not operating, with no other available option for moving air. Some vents were heavily coated with white, yellow and green powders that the inspectors believed to be residual bulk drug material from years of dust accumulation.

When inspectors questioned the staff, the QA associate director said there was no written procedure for the cleaning of the vents and no facility drawing showing the installation configuration of fans, duct work or valves.