FDA 483 - HPC Ventures, LLC - June 16, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Person
ID · 3d84acf6-af60-4303-9165-09d78ff5c522