# FDA 483 - Synergy Health Ede BV - October 09, 2023

Source: https://www.keypedia.com/records/483/synergy-health-ede-bv/084f0356-dce4-4e2d-a925-fd2633c92304

> FDA 483 for Synergy Health Ede BV on October 09, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synergy Health Ede BV
- Inspection Date: 2023-10-09
- Product Type: device
- Office Name: Foreign - CBER (Bioresearch Monitoring)
- Summary: An FDA inspection of Synergy Health Ede BV, a device contract sterilizer in Venlo, Netherlands, revealed significant deficiencies. Observations included inadequate procedures for process changes and monitoring of xray sterilization parameters. Additionally, device history records failed to demonstrate processing in accordance with master records for urethral catheters.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/synergy-health-ede-bv/eec821ae-d4fd-4242-b174-0c0b1bdd9ed8

Office: https://www.keypedia.com/offices/foreign-cber-bioresearch-monitoring/f1660531-9111-4f36-bf5d-b28bf0f3b54e