483
Pillar Biosciences Inc.Pillar Biosciences Inc. – FDA 483, Jun 4, 2021
Record Details
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.
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ID · d5267f19-4ee5-42ee-9ea3-31f7863d0eeb
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