FDA 483 - Little Rapids Corporation - August 23, 2024

An FDA inspection of Little Rapids Corporation in Green Bay, WI, revealed significant deficiencies in their quality system, many of which were repeat observations from a previous inspection. Key issues included inadequate documentation for corrective actions, lack of established procedures for incoming product acceptance and supplier control, and failure to submit a Medical Device Report (MDR) for a patient skin reaction. The findings indicate a persistent lack of adherence to quality system requirements.