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Puretone Ltd. FDA Record

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

Latest inspection OAI · Nov 20, 2008
Last warning letter 2009

Inspections 1

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Apr 10, 2009

510(k) clearances 0 None on file

Puretone Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Puretone Ltd., the most recent on Apr 10, 2009.

What these totals cover: FDA records filed under the name "Puretone Ltd." and its spelling variant "Puretone".

Latest inspection: Nov 20, 2008 · 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	1	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Puretone Ltd. FDA Warning Letters

1 warning letter on Apr 10, 2009.

Issued	Subject	Issuing office	Close-out letter
Apr 10, 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

1 inspection on Nov 20, 2008.

Date	Site	Product	Classification	FEI
Nov 20, 2008	Rochester, United Kingdom	Devices	Official Action Indicated (OAI)	3002808722

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 Puretone Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 10, 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 3002808722	Rochester, United Kingdom	1	Nov 20, 2008

Puretone Ltd. and the FDA: common questions

Has Puretone Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Puretone Ltd.. The most recent is dated Apr 10, 2009.

Has Puretone Ltd. received an FDA Form 483?

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

When did the FDA last inspect Puretone Ltd.?

The most recent FDA inspection on file ended Nov 20, 2008 at Rochester, United Kingdom and was classified OAI. FDA has 1 inspection of Puretone Ltd. on file, 1 of them classified OAI (official action indicated).

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