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Perouse Medical FDA Inspection Record

FEI 3004160911 · Inspections, Form 483s, warning letters and import refusals

Perouse Medical is an FDA-inspected facility (FEI 3004160911) located in Irigny, FR. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Dec 11, 2014: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Nov 21, 2013
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest May 10, 2012
Import refusals
1

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
Dec 11, 2014Voluntary Action Indicated (VAI)Time to report - 10 days (21 CFR 806.10(b))
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
Nov 21, 2013Official Action Indicated (OAI)Design verification - output does not meet input requirement (21 CFR 820.30(f))
Nonconforming product control (21 CFR 820.90(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Maintenance schedule, Lack of or inadequate schedule (21 CFR 820.70(g)(1))
and 5 more

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
May 10, 2012Class IIZ-2089-2014Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure…
Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential…

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIDec 11, 201410 years or older, so it adds no points0
Inspection classified OAINov 21, 201310 years or older, so it adds no points0
Class II recall Z-2089-2014, this FEI as the recalling firmMay 10, 201210 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Perouse Medical
Location
Irigny (FR)
Source
inspections

Import refusals

FDA data resources

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