Home / Facilities / 3002806833

DORNIER MEDTECH GMBH FDA Inspection Record

FEI 3002806833 · Inspections, Form 483s, warning letters and import refusals

DORNIER MEDTECH GMBH is an FDA-registered facility (FEI 3002806833) located in WESSLING Bavaria, DE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Dec 14, 2022: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Apr 29, 2011
Warning letters
1 listed by FDA for this FEI, latest Aug 26, 2011
Import refusals
2

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 14, 2022No Action Indicated (NAI)No citations listed
Apr 29, 2011Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h))
and 3 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. 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.

2 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsAug 26, 201110 years or older, so it adds no points0
Inspection classified OAIApr 29, 201110 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 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

Reviewing DORNIER MEDTECH GMBH as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check DORNIER MEDTECH GMBH yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Dornier Medtech GmbH
Location
WESSLING Bavaria (DE)
Source
device

Compliance actions

Import refusals

FDA data resources

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