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

Source: https://www.keypedia.com/records/483/hpc-ventures-llc/3d84acf6-af60-4303-9165-09d78ff5c522

> FDA 483 for HPC Ventures, LLC on June 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HPC Ventures, LLC
- Inspection Date: 2025-06-16
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: 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.

## Related Officers

- [Ruben C. Quintana](https://www.keypedia.com/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)

Company: https://www.keypedia.com/companies/hpc-ventures-llc/b4898239-a287-4654-9082-359499c0beb3

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8