FDA 483 - GSB LLC - May 03, 2024

GSB LLC, a medical device manufacturer in Nashville, TN, received a Form FDA-483 with two repeat observations during an inspection from April 11 to May 3, 2024. The firm failed to adequately establish procedures for receiving and evaluating customer complaints, specifically regarding the determination of reportable MDR events. Additionally, GSB LLC has not developed and maintained written Medical Device Reporting (MDR) procedures, indicating significant and persistent non-compliance with regulatory requirements.