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QUANTA SYSTEM, S.P.A. FDA Inspection Record

FEI 3004378299 · Inspections, Form 483s, warning letters and import refusals

QUANTA SYSTEM, S.P.A. is an FDA-registered facility (FEI 3004378299) located in SAMARATE Varese, IT. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 19, 2012: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Apr 19, 2012
Warning letters
1 listed by FDA for this FEI, latest Oct 18, 2012
Recalls as the recalling firm
2, latest Apr 27, 2021
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
Apr 19, 2012Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Procedures not adequately established or maintained (21 CFR 820.40)
Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Design control - no procedures (21 CFR 820.30(a))
and 11 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
Apr 27, 2021Class IIZ-1842-2021Olympus Sterile Optical Laser Fiber, single use and reusable and 2 more products
Product sterility is potentially compromised.
Nov 7, 2012Class IIZ-0691-2013Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of… and 2 more products
Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the…

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
Quanta System SpA
Location
SAMARATE Varese (IT)
Source
device

Compliance actions

Import refusals

FDA data resources

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