Home » Contract Manufacturer Called Out for Equipment Calibration
Contract Manufacturer Called Out for Equipment Calibration
The FDA has issued a Form 483 to contract manufacturer Advanced Machine over a flawed equipment calibration process.
The Winchester, Tennessee company was inspected from April 29-May 2 and found to have issues with its practices for calibrating equipment. Specifically, a micrometer found on the facility’s production floor had an expired calibration date but was still used to take in-process acceptance measurements for an order.
Additionally, the calibration procedure had no arrangements for including an evaluation of adverse effects on a device’s quality when testing equipment is found to be out-of-calibration.
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