FDA 483 - Little Rapids Corporation - July 17, 2019

Little Rapids Corporation, a medical device manufacturer in Green Bay, WI, was cited for significant deficiencies in its quality system. Observations included inadequate procedures for incoming product acceptance, complaint handling, corrective and preventive actions, supplier control, and nonconforming product control. The firm also failed to submit a Medical Device Report within the required timeframe and lacked documented training for internal auditors.