FDA 483 - Orly International, Inc. - December 20, 2022

An FDA inspection of Orly International, Inc. in Van Nuys, CA, revealed significant deficiencies in the manufacturing and distribution of its OTC hand sanitizers and antifungal drug products. The firm failed to establish adequate stability data for product expiration dates, lacked a robust stability program, and did not validate its water system or manufacturing equipment. Additionally, issues were noted with cleaning validation, quality control unit responsibilities, and employee cGMP training, indicating a broad lack of adherence to good manufacturing practices.