FDA 483 - Masterbilt Incorporated - June 21, 2024

Masterbilt Incorporated, a medical device manufacturer in South Bend, IN, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately validate its cleaning process, establish and follow process control procedures, and monitor process parameters. Significant issues were also found in the control of nonconforming products, the implementation and tracking of corrective and preventive actions, equipment maintenance scheduling, and the maintenance of device history records.