FDA 483 - Plasdent Corporation - November 22, 2019

Pladent Corporation, a repackager/relabeler in Pomona, CA, received a Form FDA 483 following an inspection that revealed significant deficiencies across its quality system. The firm lacked established procedures for labeling, complaint handling, Medical Device Reporting (MDR), and corrective and preventive actions (CAPA). Additionally, the firm failed to appoint a management representative to oversee quality system performance.