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

Source: https://www.keypedia.com/records/483/honeywell-healthcare-solutions-gmbh-formerly-envitec/22cc671a-59d6-447e-86c4-638e23759642

> FDA 483 for Honeywell Healthcare Solutions GmbH (formerly EnviteC) on June 20, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Honeywell Healthcare Solutions GmbH (formerly EnviteC)
- Inspection Date: 2024-06-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Albert L. Nguyen](https://www.keypedia.com/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.keypedia.com/companies/honeywell-healthcare-solutions-gmbh-formerly-envitec/8dc6b71b-7c00-4fc2-9b75-d778ef37f694

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd