FDA 483 - Accra-Pac, Inc. - November 05, 2021

Accra Pac, Inc. in Elkhart, IN, was inspected by the FDA, resulting in three observations. The inspection revealed significant deficiencies in process validation for medical devices, inadequate evaluation of out-of-calibration equipment, and failures in their corrective and preventive action system. These issues indicate a lack of robust quality system controls.