Validation procedures for production processes such as milling and lathe processes were found lacking during an October 2017 inspection of Mid South Precision’s Nashville, Tennessee facility.
According to the Form 483, contract manufacturer Mid South Precision lacked procedures for receiving, reviewing and evaluating complaints. The FDA inspector found that returned products were not logged on the customer returns log, no complaint record was opened, and it was not investigated for MDR reportability.
The company also failed to establish a device master record for any of the devices it manufactured, including the femoral array.
The FDA said the firm’s procedures for controlling nonconforming product was inadequate because products returned by customers were not adequately identified and controlled. Nonconformance reports were not opened for certain nonconforming products, and the final disposition of the products was not documented.