FDA 483 - Certified Safety Mfg Inc - October 15, 2019

Certified Safety Mfg Inc, a manufacturer/repackager in Kansas City, MO, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, equipment calibration, and device history records. Several observations, including issues with nonconforming product control, quality audit frequency, and training, were repeat findings from a previous inspection.