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Steris (Synergy Health Ede BV) FDA Record

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

Latest inspection NAI · Dec 5, 2024
No warning letters matched by name

Inspections 4

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Steris (Synergy Health Ede BV) has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Steris (Synergy Health Ede BV)" is on file.

What these totals cover: FDA records filed under the name "Steris (Synergy Health Ede BV)".

Latest inspection: Dec 5, 2024 · NAI

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	4	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Steris (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).

Steris (Synergy Health Ede BV): FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	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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Recent FDA inspections

4 inspections from Oct 15, 2008 to Dec 5, 2024.

Date	Site	Product	Classification	FEI
Dec 5, 2024	Etten-Leur, Netherlands	Devices	No Action Indicated (NAI)	3010223109
Jan 20, 2022	Etten-Leur, Netherlands	Drugs	No Action Indicated (NAI)	3010223109
Aug 28, 2015	Etten-Leur, Netherlands	Drugs	No Action Indicated (NAI)	3010223109
Oct 15, 2008	Etten-Leur, Netherlands	Drugs	No Action Indicated (NAI)	3010223109

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3010223109	Etten-Leur, Netherlands	4	Dec 5, 2024

Steris (Synergy Health Ede BV) and the FDA: common questions

Has Steris (Synergy Health Ede BV) received an FDA warning letter?

No FDA warning letter addressed to the name "Steris (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 Steris (Synergy Health Ede BV) received an FDA Form 483?

FDA has not published a Form 483 for "Steris (Synergy Health Ede BV)" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Steris (Synergy Health Ede BV)?

The most recent FDA inspection on file ended Dec 5, 2024 at Etten-Leur, Netherlands and was classified NAI. FDA has 4 inspections of Steris (Synergy Health Ede BV) on file.

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