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Otologics LLC FDA Record

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

Latest inspection NAI · Jan 26, 2011
Last warning letter 2010

Inspections 2

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Mar 5, 2010

510(k) clearances 0 None on file

Otologics LLC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Otologics LLC, the most recent on Mar 5, 2010.

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

Latest inspection: Jan 26, 2011 · NAI

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	2	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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Otologics LLC FDA Warning Letters

1 warning letter on Mar 5, 2010.

Issued	Subject	Issuing office	Close-out letter
Mar 5, 2010 · 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 Nov 19, 2009 to Jan 26, 2011.

Date	Site	Product	Classification	FEI
Jan 26, 2011	Boulder, CO	Devices	No Action Indicated (NAI)	3003590807
Nov 19, 2009	Boulder, CO	Devices	Official Action Indicated (OAI)	3003590807

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

Most recent: Warning Letter, Mar 5, 2010.

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 3003590807	Boulder, CO	2	Jan 26, 2011

Otologics LLC and the FDA: common questions

Has Otologics LLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Otologics LLC. The most recent is dated Mar 5, 2010.

Has Otologics LLC received an FDA Form 483?

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

When did the FDA last inspect Otologics LLC?

The most recent FDA inspection on file ended Jan 26, 2011 at Boulder, CO and was classified NAI. FDA has 2 inspections of Otologics LLC on file, 1 of them classified OAI (official action indicated).

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