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Mainstay Medical Limited US, Inc. — FDA Facility Profile

FEI 3013017877

Mainstay Medical Limited US, Inc. is an FDA-inspected facility (FEI 3013017877) located in Minneapolis, MN, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 30, 2023: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 NAI)
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
Jun 30, 2023No Action Indicated (NAI)No citations listed
Dec 20, 2019Voluntary Action Indicated (VAI)Sponsors' general responsibilities (21 CFR 812.40)
Sponsor progress reports for significant risk study (21 CFR 812.150(b)(5))

Facility details

Company
Mainstay Medical Limited US, Inc.
Location
Minneapolis, MN (US)
Source
inspections

FDA data resources

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