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AXIOMED LLC — FDA Facility Profile

FEI 3007746840

AXIOMED LLC is an FDA-registered facility (FEI 3007746840) located in Burlington, MA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Feb 14, 2014: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
2

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
Feb 14, 2014Voluntary Action Indicated (VAI)No investigator agreement (21 CFR 812.43(c))
Sponsor securing investigator compliance (21 CFR 812.46(a))

Facility details

Company
Axiomed Spine Corporation
Location
Burlington, MA (US)
Source
device

Import refusals

FDA data resources

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