Molder Rubber and Plastic Corporation (MRPC) – FDA 483, Dec 16, 2024

Molder Rubber and Plastic Corporation (MRPC) in Butler, WI, received a Form FDA-483 citing significant deficiencies across its quality system. Observations included inadequate process validation, insufficient vendor qualification procedures, and failures in corrective and preventive action processes. Additionally, the firm lacked adequate controls for nonconforming products, specifically regarding out-of-calibration equipment and the assessment of expired materials.