FDA 483 - Sharp Packaging Services, LLC - January 28, 2022

An FDA inspection of Sharp Packaging Services, LLC revealed significant deficiencies across its packaging operations. The firm failed to adhere to quality control unit responsibilities, maintain adequate documentation practices, and ensure proper facility and equipment controls. These issues included inconsistent change control assessments, non-contemporaneous record-keeping, incomplete complaint investigations, and a lack of procedures for warehousing and data backup, indicating systemic problems in their quality management system.