The FDA came down on Oakdale Precision, a contract manufacturer, for failing to establish medical device reporting and design control procedures.
The agency discovered during its Nov. 29-Dec. 6, 2018 inspection that the Oakdale, Minnesota company had no procedures in place for handling medical device report events.
The firm also failed to document or complete design activities for a wheeled stretcher product, including design and development planning, design review, verification and validation, among others.
