FDA 483 - Summit Industries Inc. - September 30, 2022

Summit Industries Inc. in Miles, IL, a device manufacturer, received a Form 483 with four observations following an FDA inspection. The firm was cited for failing to submit timely malfunction reports to manufacturers, not promptly reviewing and investigating MDR-reportable complaints, and inadequately establishing procedures for incoming acceptance activities. These findings highlight deficiencies in the firm's quality system, particularly concerning post-market surveillance and complaint management.