FDA 483 - PediFix, Inc. - February 12, 2024

Pedifix, Inc. in Brewster, NY, a repackager/relabeler, was cited for three significant issues during an FDA inspection. The firm failed to ensure proper quality control over contract manufactured drug products, lacked validated computer controls for inventory management, and did not visually examine reserve samples for deterioration. These observations indicate deficiencies in quality unit responsibilities, data integrity, and sample retention procedures.