FDA 483 - Johnson Medtech LLC - June 06, 2019

Johnson Medtech LLC, a medical device contract manufacturer in Vandalia, OH, received six observations during an FDA inspection. The firm was cited for inadequate procedures concerning process validation, corrective and preventive actions, and the control of nonconforming product. Additional deficiencies included failures to maintain product acceptance status, establish complaint handling procedures, and adequately document device history records.