FDA 483 - Viant Medical Company - August 22, 2018

An FDA inspection of MedPlast Medical, Inc. in Grand Rapids, MI, a contract manufacturer and sterilizer, revealed two significant observations. The firm failed to establish adequate procedures for controlling environmental conditions in its clean room and for implementing a robust corrective and preventive action (CAPA) system, including statistical analysis of quality data. These issues indicate deficiencies in the firm's quality system.