FDA 483 - Pillar Biosciences Inc. - June 04, 2021

An FDA inspection of Pillar Biosciences Inc. in Natick, MA, a medical device manufacturer, identified two significant issues. The firm failed to adequately document process validation, specifically for its HVAC Monitoring and Control System's operation qualification. Additionally, calibration procedures lacked provisions for remedial action when monitoring and measuring equipment did not meet accuracy and precision limits.