483
Honeywell Healthcare Solutions GmbH (formerly EnviteC)FDA 483 - Honeywell Healthcare Solutions GmbH (formerly EnviteC) - June 20, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Inspection Date
- June 20, 2024
- Product Type
- Device
Open in Dashboard
ID · 22cc671a-59d6-447e-86c4-638e23759642