FDA 483 - Neurotronics LLC. - May 05, 2022

Neurotronics, Inc., a manufacturer in Gainesville, FL, was cited for failing to adequately establish and follow procedures for purchasing controls. The firm did not implement required quality agreements or perform quality audits for critical and non-critical suppliers as mandated by its own established procedures. This indicates a significant lapse in ensuring purchased products and services conform to specified requirements.