FDA 483 - High Technology, Inc. - August 05, 2021

High Technology, Inc. in North Attleboro, MA, a medical device manufacturer, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding supplier corrective actions for low quality cards. Additionally, their calibration procedures lacked provisions for remedial action to assess the impact on device quality when accuracy and precision limits were not met.