FDA 483 - Suture Concepts - December 20, 2021

Suture Concepts in Beverly, MA, a manufacturer of medical devices, was cited with four observations during an FDA inspection. The inspection revealed deficiencies in process validation, finished device acceptance procedures, statistical rationale for sampling plans, and maintenance of the device master record for their Lead Loop Suture Anchor. These issues indicate a lack of adequate controls over manufacturing processes and quality system documentation.