FDA 483 - MD Pharmaceutical Supply, LLC - July 16, 2025

MD Pharmaceutical Supply, LLC, an API warehouse and drug distributor in Hanover, PA, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to establish adequate procedures for returned goods, qualify facilities and equipment, calibrate monitoring devices, and control rejected materials. Additionally, issues with recall procedures, computer system controls, and building suitability were noted, indicating a broad lack of adherence to quality standards.