FDA 483 - Curonix LLC - November 08, 2023

Curonix LLC, a medical device manufacturer in Pompano Beach, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, software validation, and the disposition of nonconforming products. These issues led to the distribution of mislabeled stimulators and a subsequent market withdrawal.