FDA 483 - Stingray Surgical Products, LLC - February 09, 2023

During an inspection from January 31 to February 9, 2023, Stingray Surgical Products, LLC in Boca Raton, FL, was cited for deficiencies in its quality system. The FDA observed that the firm's procedures for design change were not adequately established, specifically regarding documentation of verification and validation. Additionally, the company failed to adequately establish procedures for corrective and preventive action, as evidenced by not opening a CAPA for a previous FDA inspection observation.