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Vygon US LLC D/B/A Vygon Neuro FDA Inspection Record

FEI 2518608 · Inspections, Form 483s, warning letters and import refusals

Vygon US LLC D/B/A Vygon Neuro is an FDA-inspected facility (FEI 2518608) located in Norristown, PA, US. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Jun 26, 2009: No Action Indicated (NAI)
Inspections on record
1 (1 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
Jun 26, 2009No Action Indicated (NAI)Documentation (21 CFR 820.75(a))
Investigation of device failures (21 CFR 820.198(c))
Design validation acceptance criteria (21 CFR 820.30(g))
Documentation of disposition, justification, signature (21 CFR 820.90(b)(1))
and 2 more

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. No OAI or VAI inspection, warning letter, Class I or II recall, or counted import refusals for this FEI in the records we hold.

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.

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
Vygon US LLC D/B/A Vygon Neuro
Location
Norristown, PA (US)
Source
inspections

FDA data resources

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