FDA 483 - Signal Medical Corporation - April 10, 2023

An FDA inspection of Signal Medical Corporation, a medical device establishment, was conducted from April 3-10, 2023. The inspection revealed four key observations indicating deficiencies in the company's quality system and compliance with regulatory requirements, particularly regarding the Quality System Regulation (21 CFR 820). The first observation noted inadequate statistical techniques; specifically, pyrogen/endotoxin testing for Class II implants had not been performed since March 2020 as required, and sample sizes for packaging validation were not statistically justified. Secondly, Design History Files (DHFs) were not maintained according to current design control procedures, with missing risk management deliverables for products such as the Symmetric Total Knee System. Thirdly, the firm failed to adequately monitor critical high-risk suppliers, as several had not been audited at the defined frequency. Finally, training procedures were insufficient, highlighted by the President, a recall committee member, lacking required training on the device recall procedure. Signal Medical Corporation has committed to correcting all identified observations.