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Medical Devices / Inspections and Audits

Out-of-Calibration Equipment Plagues Contract Manufacturer

May 31, 2018
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Not only was equipment found to be out of calibration at All Quality & Services’ Fremont, Calif. facility, but the contract 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.

The FDA also found that the firm failed to document corrective and preventive actions and 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.

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