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MAQUET S.A.S. FDA Inspection Record

FEI 3002465150 · Inspections, Form 483s, warning letters and import refusals

MAQUET S.A.S. is an FDA-registered facility (FEI 3002465150) located in ARDON, ORLEANS CEDEX 2 Loiret, FR. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jan 16, 2025: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 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
Recalls as the recalling firm
3, latest Aug 7, 2026
Import refusals
3

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
Jan 16, 2025No Action Indicated (NAI)Lack of or inadequate DHR procedures (21 CFR 820.184)
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Feb 1, 2018Voluntary Action Indicated (VAI)Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of or inadequate process validation (21 CFR 820.75(a))
Feb 7, 2013No Action Indicated (NAI)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
Aug 7, 2026Class IIZ-3224-2026PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model…
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
Jun 14, 2018Class IIZ-2502-2018VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF…
Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the…
Apr 19, 2018Class IIZ-1937-2018VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017…
Potential keypad failure on VOLISTA StandOP Surgical Lights.

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
Maquet SAS
Location
ARDON, ORLEANS CEDEX 2 Loiret (FR)
Source
device

Import refusals

FDA data resources

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