FDA 483 - HPC Ventures, LLC - June 16, 2025

HPC Ventures dba HPC Global, a packer and labeler in Hanover, PA, was cited for ten significant violations during an FDA inspection. The firm released expired OTC drug products, lacked validated processes and equipment qualification, and failed to maintain adequate quality control, record-keeping, stability data, and environmental controls. These issues indicate a systemic failure to adhere to cGMP requirements, posing potential risks to drug product quality and patient safety.