FDA 483 - Medipharm Laboratories, Inc. - February 23, 2024

An FDA inspection of Medipharm Laboratories, Inc. in Miami, FL, a contract testing laboratory, revealed significant deficiencies in their quality system and employee training. The firm failed to maintain written Quality Agreements with all clients and an outsource contractor, and did not follow its own annual review procedure. Additionally, employees in the Quality Unit and Laboratory operations lacked documented training in cGMP, cGLP, or cGDP.