Bi-Coastal Pharma International – FDA 483, Jan 14, 2022

Bi-Coastal Pharma International, an own label distributor in Shrewsbury, NJ, was cited for significant deficiencies in its quality control unit, particularly concerning oversight of contract manufacturers and adherence to GMP documentation practices. The inspection revealed a lack of written procedures for quality oversight, an absence of a stability testing program, and inadequate complaint handling and investigation processes. Furthermore, the firm's QA Manager was found to lack the necessary experience and training for their assigned responsibilities.