FDA 483 - WAVi Co. - December 16, 2024

WAVI Co., a medical device manufacturer in Denver, CO, received a Form 483 with ten observations during a recent inspection, several of which are repeat findings. The inspection highlighted significant deficiencies across its quality system, including inadequate design history files, CAPA procedures, complaint handling, risk analysis, and document control. These issues collectively indicate a systemic failure to adhere to regulatory requirements and maintain adequate documentation practices.