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.
For example, one product was returned due to pits in the weld, and a nonconformance report was not opened and the final disposition was not documented.
Rework and reevaluation activities were also found to be missing in the device history record. For example, for the same product returned, the pieces were reworked, but there was no documentation of rework activities in the device history record.
CAPA procedures were also inadequate. A quality audit was performed in June 2017, which identified deficiencies, but corrective actions were not initiated until October 2017, after the FDA inspection was announced, the agency said.
In addition, the FDA found fault with the firm’s supplier selection, evaluation and approval procedures. Procedures in place didn’t ensure that suppliers, contractors and consultants were being evaluated by their ability to meet specified requirements. Mid South Precision also did not establish and maintain acceptable records of its suppliers, and it lacked records of supply agreements.
Read the Mid South Precision Form 483 here: www.fdanews.com/03-01-18-midsouthprecisioninc483.pdf.