FDA 483 - Welch, Holme & Clark Co., Inc - July 10, 2024

An FDA inspection of Welch, Holme & Clark Co., Inc. in Newark, NJ, revealed significant deficiencies in their quality control unit. Observations included a lack of appropriate controls over computerized systems, inadequate written procedures for quality control responsibilities and external lab qualification, and insufficient CGMP training for laboratory personnel. These issues indicate a serious lack of oversight in critical areas of their repacking operations.