FDA 483 - ARCH-Blandon - February 07, 2020

During an inspection of Ipsmac Machine Co Inc in Blandon, PA, a medical device manufacturer, the FDA observed a significant issue related to equipment calibration and documentation. The firm failed to document evaluations and remedial actions for out-of-calibration equipment, specifically a digital indicator used for in-process testing that was out of calibration for three months. This indicates a lapse in quality system controls regarding equipment maintenance and record-keeping.