FDA 483 - Honeywell Healthcare Solutions GmbH (formerly EnviteC) - June 20, 2024

An FDA inspection of Honeywell Healthcare Solutions GmbH (formerly EnvitesC) in Wismar, Germany, a manufacturer of pulse oximeter devices, revealed three significant observations. The firm was cited for inadequate procedures related to complaint handling, equipment inspection, and design change control. These issues indicate deficiencies in the firm's quality system for medical device manufacturing.