FDA 483 - Stand Aid Of Iowa Inc - March 03, 2022

Stand Aid Of Iowa Inc, a medical device manufacturer in Sheldon, IA, was inspected and received a Form FDA 483 with seven observations. The inspection revealed significant issues across quality system procedures, including inadequate control of non-conforming products, deficiencies in device history records, lack of established procedures for product identification and document control, and insufficient personnel training documentation. Several observations were noted as repeat findings from a previous inspection, indicating persistent compliance problems.