FDA 483 - Revolutionary Science - April 06, 2022

Revolutionary Science, a medical device manufacturer in Shafer, MN, received seven observations during an FDA inspection. The firm was cited for significant deficiencies across its quality system, including inadequate device history records, lack of proper design change controls, and failures in medical device reporting and complaint handling procedures. Additionally, the company lacked established procedures for corrective and preventive actions, control of non-conforming products, and personnel training.