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Zach System S.A. FDA Record

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

Latest inspection VAI · Feb 12, 2021
Last warning letter 2009

Inspections 5

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Oct 23, 2009

510(k) clearances 0 None on file

Zach System S.A. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Zach System S.A., the most recent on Oct 23, 2009.

What these totals cover: FDA records filed under the name "Zach System S.A." and its spelling variant "Zach System".

Latest inspection: Feb 12, 2021 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	5	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Zach System S.A.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Zach System S.A.: 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	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	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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Zach System S.A. FDA Warning Letters

1 warning letter on Oct 23, 2009.

Issued	Subject	Issuing office	Close-out letter
Oct 23, 2009 · 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 Jun 11, 2009 to Feb 12, 2021.

Date	Site	Product	Classification	FEI
Feb 12, 2021	Avrille Cedex, France	Drugs	Voluntary Action Indicated (VAI)	3002808164
Dec 7, 2017	Avrille Cedex, France	Drugs	Voluntary Action Indicated (VAI)	3002808164
Oct 16, 2014	Avrille Cedex, France	Drugs	No Action Indicated (NAI)	3002808164
Dec 2, 2010	Avrille Cedex, France	Drugs	No Action Indicated (NAI)	3002808164
Jun 11, 2009	Avrille Cedex, France	Drugs	Official Action Indicated (OAI)	3002808164

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 Zach System S.A.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 23, 2009.

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 3002808164	Avrille Cedex, France	5	Feb 12, 2021

Zach System S.A. and the FDA: common questions

Has Zach System S.A. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Zach System S.A.. The most recent is dated Oct 23, 2009.

Has Zach System S.A. received an FDA Form 483?

FDA has not published a Form 483 for "Zach System S.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Zach System S.A.?

The most recent FDA inspection on file ended Feb 12, 2021 at Avrille Cedex, France and was classified VAI. FDA has 5 inspections of Zach System S.A. on file, 1 of them classified OAI (official action indicated).

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