Not only was equipment found to be out of calibration at All Quality & Services’ Fremont, Calif. facility, but the contract device manufacturer failed to document remedial actions, CAPA activities or investigate complaints, a January to February FDA inspection found.
The five-item Form 483 said that multimeters used to measure voltage of printed circuit boards (PCBs) and components were not calibrated. Voltage testing for PCBs is one of the final quality control tests performed on the boards before assembly into a finished device for shipment.
During a walkthrough, the inspector observed that the facility lacked identification and calibration information for its multimeters. “We asked the VP of Operation for the calibration records; however, he stated there were no records and the multimeters had not been calibrated,” according to the 483.
The firm makes laboratory devices and surgical equipment including orthopedic surgical aids, image-guided catheter systems and image generators.
The FDA also found that the firm failed to document corrective and preventive and it failed to open a CAPA after being notified by a third party audit that the multimeters used to measure the voltage of the main board were not calibrated. Four CAPAs that were reviewed were closed before the effectiveness of the corrective actions could be verified.
The agency also cited the contract manufacturer for not documenting personnel training or acceptance activities.