FDA 483 - Tektone Sound & Signal Mfg.Inc. - September 26, 2019

Tektone Sound & Signal Mfg.Inc. in Franklin, NC, a manufacturer of Class II medical devices, was cited for multiple significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, device history records, finished device acceptance, unique device identification, manufacturing documentation, medical device reporting, and employee training. These issues indicate a systemic lack of established and documented processes crucial for ensuring device quality and regulatory compliance.