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Nipro Vascular Innovations Americas, Inc. FDA Inspection Record

FEI 3015551113 · Inspections, Form 483s, warning letters and import refusals

Nipro Vascular Innovations Americas, Inc. is an FDA-registered facility (FEI 3015551113) located in Bedford, MA, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 4, 2025: No Action Indicated (NAI)
Inspections on record
7 (1 VAI, 6 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
Mar 4, 2025No Action Indicated (NAI)No citations listed
Jan 9, 2024No Action Indicated (NAI)No citations listed
Dec 8, 2021No Action Indicated (NAI)No citations listed
Jun 2, 2017No Action Indicated (NAI)No citations listed
Apr 10, 2015No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Environmental control Lack of or inadequate procedures (21 CFR 820.70(c))
Nov 15, 2012Voluntary Action Indicated (VAI)Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
Failure to submit (21 CFR 1002.13)
Report of Death or Serious Injury (21 CFR 803.50(a)(1))
Oct 29, 2009No Action Indicated (NAI)No citations listed

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 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 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Nipro Vascular Innovations Americas Inc
Location
Bedford, MA (US)
Source
device

FDA data resources

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