FDA 483 - Trewavis Surgical Instruments Pty Ltd. - August 17, 2022

Trewavis Surgical Instruments Pty Ltd. in Bayswater, Australia, received a Form FDA 483 following an inspection. The inspection revealed two significant issues related to the firm's quality system, specifically concerning the inadequate implementation of procedures for finished device acceptance and equipment maintenance. These observations indicate deficiencies in ensuring product quality and operational control.