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.