FDA 483 - Bi-Coastal Pharma International - September 14, 2020

Bi-Coastal Pharma International, an own label distributor/marketer in Shrewsbury, NJ, was inspected by the FDA from September 8-14, 2020. The inspection revealed a significant deficiency related to the lack of written procedures for handling post-marketing adverse drug experiences. This indicates a serious gap in their pharmacovigilance system.