FDA 483 - Evoqua Water Technologies, LLC - February 24, 2022

An FDA inspection of Evoqua Water Technologies, LLC in Lowell, MA, a manufacturer of water treatment systems for dialysis, identified two significant observations. The firm failed to perform internal quality audits at defined intervals for 2019 and 2021 without documented justification. Additionally, device history records for Class II medical devices lacked the required unique device identifier (UDI).