Home / Companies / Vygon GmbH & Co. KG

Vygon GmbH & Co. KG FDA Record

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

Vygon GmbH & Co. KG has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Vygon GmbH & Co. KG, the most recent on Aug 4, 2014.

What these totals cover: FDA records filed under the name "Vygon GmbH & Co. KG" and its spelling variant "Vygon Gmbh And Co. Kg". Records filed under related names are not included; see Related names.

Latest recall: Z-0113-2015 · Aug 28, 2014 · filed under Vygon Corporation
Latest inspection: Sep 4, 2025 · NAI

Newer recall under related name Vygon Corporation: Aug 28, 2014, Z-0113-2015.

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	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Vygon GmbH & Co. KG'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	0	0	0	0	0
2025	1	0	0	0	0
2024	0	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	1	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.

Reviewing Vygon GmbH & Co. KG as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Vygon GmbH & Co. KG yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Vygon GmbH & Co. KG above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Vygon Corporation Combines 2 spellings Vygon Corporation: 14 recalls, 1 510(k) Vygon: 52 510(k)s, 5 inspections	Same company group	14	53	5	0	Aug 28, 2014 (Z-0113-2015)

Vygon GmbH & Co. KG FDA Warning Letters

1 warning letter on Aug 4, 2014.

Issued	Subject	Issuing office	Close-out letter
Aug 4, 2014 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

5 inspections from Mar 20, 2014 to Sep 4, 2025.

Date	Site	Product	Classification	FEI
Sep 4, 2025	Aachen, Germany	Devices	No Action Indicated (NAI)	3002808464
Nov 10, 2022	Aachen, Germany	Devices	Voluntary Action Indicated (VAI)	3002808464
Aug 16, 2018	Aachen, Germany	Devices	No Action Indicated (NAI)	3002808464
Jan 29, 2015	Aachen, Germany	Devices	Voluntary Action Indicated (VAI)	3002808464
Mar 20, 2014	Aachen, Germany	Devices	Official Action Indicated (OAI)	3002808464

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Vygon GmbH & Co. KG: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Aug 4, 2014.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002808464	Aachen, Germany	5	Sep 4, 2025

Vygon GmbH & Co. KG and the FDA: common questions

Has Vygon GmbH & Co. KG received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Vygon GmbH & Co. KG. The most recent is dated Aug 4, 2014.

Has Vygon GmbH & Co. KG received an FDA Form 483?

FDA has not published a Form 483 for "Vygon GmbH & Co. KG" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Vygon GmbH & Co. KG?

The most recent FDA inspection on file ended Sep 4, 2025 at Aachen, Germany and was classified NAI. FDA has 5 inspections of Vygon GmbH & Co. KG on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Vygon GmbH & Co. KG in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.