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FUJIFILM Medwork GmbH FDA Inspection Record

FEI 3020707080 · Inspections, Form 483s, warning letters and import refusals

FUJIFILM Medwork GmbH is an FDA-registered facility (FEI 3020707080) located in Hochstadt/Aisch Bavaria, DE. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Mar 26, 2025: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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
Form 483 and inspection documents
1 in FDA's reading room

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 26, 2025Voluntary Action Indicated (VAI)Individual Report of Malfunction (21 CFR 803.50(a)(2))

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Mar 26, 2025, which is not always the inspection or issue date. Published by FDA Nov 12, 2026.

FDA record score

6 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 14, 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.

1 record behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 26, 20256 x 16

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
FUJIFILM MEDWORK GMBH
Location
Hochstadt/Aisch Bavaria (DE)
Source
device

FDA data resources

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