PL Cosmetic – FDA 483, Jul 1, 2022

PL Cosmetic, a manufacturer in Namdong, Korea, was cited for significant deficiencies in its laboratory and production systems. The inspection revealed issues including falsified stability data, inadequate laboratory controls for electronic records and equipment, and a lack of scientifically sound sampling plans. Additionally, the firm failed to conduct annual visual examinations of reserve samples and lacked written procedures for validating and controlling manufacturing processes.