FDA 483 - Bernz Medical Sales LLC - March 11, 2019

An FDA inspection of Bern Medical Sales LLC in Ewa Beach, HI, an HCT/P Distributor, revealed two significant observations. The firm failed to establish and document procedures for the receipt, shipment, and distribution of HCT/Ps, and also lacked written procedures for the review, evaluation, documentation, and investigation of complaints related to core CGTP requirements. These issues indicate a lack of fundamental quality system controls.