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MicroPort CRM S.R.L. FDA Inspection Record

FEI 1000165971 · Inspections, Form 483s, warning letters and import refusals

MicroPort CRM S.R.L. is an FDA-registered facility (FEI 1000165971) located in Saluggia (VC) Vercelli, IT. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Mar 28, 2013: Voluntary Action Indicated (VAI)
Inspections on record
3 (1 OAI, 2 VAI)
Last OAI inspection
Jul 2, 2009
Warning letters
1 listed by FDA for this FEI, latest Oct 29, 2009
Recalls as the recalling firm
3, latest Jul 24, 2017
Import refusals
4

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 28, 2013Voluntary Action Indicated (VAI)Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Submission of Supplement to Individual Report Within One Month (21 CFR 803.56)
Mar 3, 2011Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Quality audits - Lack of or inadequate procedures (21 CFR 820.22)
Lack of or inadequate procedures (21 CFR 820.100(a))
Jul 2, 2009Official Action Indicated (OAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Jul 24, 2017Class IIZ-3228-2017Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter… and 5 more products
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization…
Apr 11, 2017Class IIZ-2112-2017OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR… and 2 more products
Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
Nov 20, 2013Class IIZ-0805-2014ORCHESTRA/ORCHESTRA PLUS Programmer
Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its…

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
MicroPort CRM S.R.L.
Location
Saluggia (VC) Vercelli (IT)
Source
device

Compliance actions

Import refusals

FDA data resources

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