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Synergy Health Ede BV FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Synergy Health Ede BV has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Synergy Health Ede BV" is on file. FDA has published 1 Form 483 for Synergy Health Ede BV.

What these totals cover: FDA records filed under the name "Synergy Health Ede BV" and its spelling variant "Synergy Health Ede".

Latest inspection: Feb 12, 2026 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Synergy Health Ede BV's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	1	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Synergy Health Ede BV Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Oct 12, 2023	483	3020976354

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

7 inspections from Mar 9, 2010 to Feb 12, 2026.

Date	Site	Product	Classification	FEI
Feb 12, 2026	Ede, Netherlands	Devices	Voluntary Action Indicated (VAI)	3002807038
Oct 12, 2023	Venlo, Netherlands	Devices	Voluntary Action Indicated (VAI)	3020976354
Feb 7, 2019	Ede, Netherlands	Devices	No Action Indicated (NAI)	3002807038
Dec 3, 2015	Ede, Netherlands	Devices	Voluntary Action Indicated (VAI)	3002807038
Nov 13, 2015	Venlo, Netherlands	Devices	No Action Indicated (NAI)	3009337401
Jan 30, 2014	Ede, Netherlands	Devices	Voluntary Action Indicated (VAI)	3002807038
Mar 9, 2010	Ede, Netherlands	Devices	No Action Indicated (NAI)	3002807038

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002807038	Ede, Netherlands	5	Feb 12, 2026
FEI 3020976354	Venlo, Netherlands	1	Oct 12, 2023
FEI 3009337401	Venlo, Netherlands	1	Nov 13, 2015

Synergy Health Ede BV and the FDA: common questions

Has Synergy Health Ede BV received an FDA warning letter?

No FDA warning letter addressed to the name "Synergy Health Ede BV" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Synergy Health Ede BV received an FDA Form 483?

FDA has published 1 Form 483 for Synergy Health Ede BV in its reading room, the most recent dated Oct 12, 2023. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Synergy Health Ede BV?

The most recent FDA inspection on file ended Feb 12, 2026 at Ede, Netherlands and was classified VAI. FDA has 7 inspections of Synergy Health Ede BV on file.

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