FDA 483 - Rehabtronics Inc. - August 08, 2013

Rehabtronics Inc., a medical device manufacturer in Edmonton, Alberta, received a Form FDA 483 citing multiple significant quality system deficiencies. Observations included inadequate procedures for design validation, corrective and preventive actions, device history records, complaint handling, and management review. The firm failed to conduct required validations, investigate complaints, and maintain complete device history records for its ReJoyce rehabilitation device.