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Otologics LLC FDA Inspection Record

FEI 3003590807 · Inspections, Form 483s, warning letters and import refusals

Otologics LLC is an FDA-inspected facility (FEI 3003590807) located in Boulder, CO, US. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jan 26, 2011: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Nov 19, 2009
Warning letters
1 listed by FDA for this FEI, latest Mar 5, 2010
Import refusals
1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jan 26, 2011No Action Indicated (NAI)No citations listed
Nov 19, 2009Official Action Indicated (OAI)Sponsors' general responsibilities (21 CFR 812.40)
Sponsor securing investigator compliance (21 CFR 812.46(a))
Sponsor correspondence records inadequate (21 CFR 812.140(b)(1))
Sponsor device shipment records inadequate (21 CFR 812.140(b)(2))
and 2 more

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

2 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsMar 5, 201010 years or older, so it adds no points0
Inspection classified OAINov 19, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Otologics LLC
Location
Boulder, CO (US)
Source
inspections

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.