FDA 483 - Laboratorios Cosmodent SL - September 02, 2022

Laboratorios Cosmodent SL, an OTC drug manufacturer in Guarnizo, Spain, received a Form FDA 483 with five observations during an inspection from 8/29/2022 to 9/2/2022. The observations highlight significant deficiencies in quality control unit responsibilities, computer system controls, laboratory testing procedures, equipment design and cleaning, and labeling control. Several issues, including equipment design and labeling control, were repeat observations from a previous inspection.