G Surgical LLC – FDA EIR

An FDA inspection of G Surgical LLC, a manufacturer of Class II orthopedic and neurosurgical devices, was conducted from February 27 to March 1, 2023. The inspection assessed the firm's compliance with the Quality System Regulation (21 CFR Part 820), focusing on key areas including Management Control, Corrective and Preventive Actions, Design Control, and Production and Process Controls. The most significant finding, documented on an FDA-483 form, was the company's failure to establish and maintain adequate procedures for the acceptance of incoming products, specifically lacking documentation for the inspection and logging of raw materials or components since 2019, a violation of 21 CFR 820.80(b). Additionally, several verbal observations were made, highlighting inadequacies in the Medical Device Reporting (MDR) procedure (21 CFR 803), which was found vague and outdated. The complaint handling procedure lacked specific timelines for closure, and the recall procedure did not reference the 10-day FDA reporting timeframe (21 CFR 806). The Design Control procedure was also noted as insufficient in addressing all elements of 21 CFR 820.30. G Surgical LLC's management committed to correcting the FDA-483 observation and submitting a written response within 15 business days, indicating a need for comprehensive updates to their quality system procedures to achieve full compliance.