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Hyphen BioMed Sasu FDA Record

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

Latest inspection OAI · Feb 13, 2014
Last warning letter 2012

Inspections 2

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 5, 2012

510(k) clearances 0 None on file

Hyphen BioMed Sasu has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Hyphen BioMed Sasu, the most recent on Sep 5, 2012.

What these totals cover: FDA records filed under the name "Hyphen BioMed Sasu".

Latest inspection: Feb 13, 2014 · OAI

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

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Hyphen BioMed Sasu FDA Warning Letters

1 warning letter on Sep 5, 2012.

Issued	Subject	Issuing office	Close-out letter
Sep 5, 2012 · 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

2 inspections from Jun 20, 2012 to Feb 13, 2014.

Date	Site	Product	Classification	FEI
Feb 13, 2014	Neuville-Sur-Oise, France	Devices	Official Action Indicated (OAI)	3004434070
Jun 20, 2012	Neuville-Sur-Oise, France	Devices	Official Action Indicated (OAI)	3004434070

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 Hyphen BioMed Sasu: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 5, 2012.

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 3004434070	Neuville-Sur-Oise, France	2	Feb 13, 2014

Hyphen BioMed Sasu and the FDA: common questions

Has Hyphen BioMed Sasu received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Hyphen BioMed Sasu. The most recent is dated Sep 5, 2012.

Has Hyphen BioMed Sasu received an FDA Form 483?

FDA has not published a Form 483 for "Hyphen BioMed Sasu" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hyphen BioMed Sasu?

The most recent FDA inspection on file ended Feb 13, 2014 at Neuville-Sur-Oise, France and was classified OAI. FDA has 2 inspections of Hyphen BioMed Sasu on file, 2 of them classified OAI (official action indicated).

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