483
Honeywell Healthcare Solutions GmbH (formerly EnviteC)Honeywell Healthcare Solutions GmbH (formerly EnviteC) – FDA 483, Jun 20, 2024
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
View Company Profile
ID · 22cc671a-59d6-447e-86c4-638e23759642
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.