FDA 483 - ECI Pharmaceuticals, LLC - November 18, 2016

BCT Pharmaceuticals LLC, a prescription drug manufacturer in Ft Lauderdale, FL, was cited for six observations during an FDA inspection. The findings indicate significant deficiencies across production, facilities, equipment, and laboratory control systems, including inadequate in-process controls, poorly designed and maintained equipment, insufficient cleaning procedures, and a lack of environmental controls to prevent cross-contamination, exacerbated by ongoing construction. Additionally, the firm exhibited poor contemporaneous documentation practices in the laboratory.