FDA 483 - Sharp Packaging Services, LLC - June 24, 2003

Sharp Corp, a contract pharmaceutical packager in Conshohocken, PA, was cited for multiple deficiencies related to quality control, investigations, reprocessing, and documentation during an FDA inspection. The observations highlight issues with inadequate investigations into product failures, insufficient container closure protection, improper handling of failing drug products, and lack of proper training and quality unit oversight for reprocessing and testing methods. These issues indicate a systemic breakdown in ensuring product quality and compliance with CGMP requirements.