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Legend Spine, LLC — FDA Facility Profile

FEI 3015176639

Legend Spine, LLC is an FDA-inspected facility (FEI 3015176639) located in Bethlehem, PA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Aug 8, 2019: 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

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
Aug 8, 2019Voluntary Action Indicated (VAI)Quality Audit/Reaudit - conducted (21 CFR 820.22)
Management review - defined interval, sufficient frequency (21 CFR 820.20(c))

Facility details

Company
Legend Spine, LLC
Location
Bethlehem, PA (US)
Source
inspections

FDA data resources

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