FDA 483 - Packaging Coordinators, LLC - October 21, 2022

Packaging Coordinators, LLC, a biological product and drug labeler and packager in Philadelphia, PA, was cited for two observations during an FDA inspection. The firm failed to maintain its manufacturing buildings in a clean and sanitary condition, with observations of dirt, rust, residue, and water stains. Additionally, the quality control unit did not fully follow its procedures, specifically regarding effectiveness checks for Corrective and Preventive Actions (CAPA) and proper implementation of change control.