FDA 483 - AmerisourceBergen Drug Corp. - June 15, 2023

An FDA inspection of AmerisourceBergen Drug Corp., a warehouse distributor in Morrisville, NC, revealed significant deficiencies in its operations related to dietary supplements. The firm was cited for lacking quality control for returned supplements, failing to collect reserve samples, and not establishing written procedures for handling returned supplements, as well as for general holding and distribution activities. These observations indicate a lack of adequate controls over the firm's dietary supplement operations.