FDA 483 - Curonix LLC - November 08, 2023

During an inspection from October 18 to November 8, 2023, the FDA identified significant quality system deficiencies at Curonix LLC, a medical device manufacturer in Pompano Beach, FL. The inspection revealed that the company’s procedures for corrective and preventive actions were inadequate. Specifically, a nonconformity involving an invalid barcode (incorrect expiration date “56”) on stimulator kits, which prevented scanning during implant, was not thoroughly investigated to identify all contributing factors.

Furthermore, Curonix LLC's complaint handling system was found to be deficient. The firm’s procedures for evaluating complaints led to inappropriate “No Problem/Fault Found” conclusions for serious reported issues like device erosion or broken components. The company also failed to adequately review complaint logs for recurring issues related to specific product lots, such as multiple instances of unscannable labels for lot SWO220726.

Critical software used in production and the quality system, including off-the-shelf barcode generation software, had not been properly validated for its intended use, despite a prior corrective action plan. This lack of validation contributed to the distribution of nonconforming products and a subsequent market withdrawal. Finally, the firm did not follow its own established procedures for handling nonconforming products during a market withdrawal, specifically by failing to complete a Health Hazard Evaluation for mislabeled stimulator kits. Curonix LLC has acknowledged these observations and promised to correct the identified issues, which fall under the FDA's Quality System Regulation for medical devices.