Home / Facilities / 3004595684

TROKAMED GMBH FDA Inspection Record

FEI 3004595684 · Inspections, Form 483s, warning letters and import refusals

TROKAMED GMBH is an FDA-registered facility (FEI 3004595684) located in GEISINGEN Baden-Wurttemberg, DE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Feb 19, 2016: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Jun 27, 2013
Warning letters
1 listed by FDA for this FEI, latest Nov 22, 2013
Recalls as the recalling firm
1, latest Nov 27, 2024
Import refusals
1

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
Feb 19, 2016Voluntary Action Indicated (VAI)Documentation (21 CFR 820.100(b))
Jun 27, 2013Official Action Indicated (OAI)Quality audits - auditor independence (21 CFR 820.22)
Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h))
Software validation for automated processes (21 CFR 820.70(i))
DHR content (21 CFR 820.184)
and 2 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
Nov 27, 2024Class IZ-0713-2025Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access… and 3 more products
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone…

FDA record score

15 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 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.

4 records behind this number
RecordDatePoints x age weightAdds
Class I recall Z-0713-2025, this FEI as the recalling firmNov 27, 202415 x 115
Inspection classified VAIFeb 19, 201610 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsNov 22, 201310 years or older, so it adds no points0
Inspection classified OAIJun 27, 201310 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 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

Reviewing TROKAMED 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 TROKAMED 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
Trokamed GmbH
Location
GEISINGEN Baden-Wurttemberg (DE)
Source
device

Compliance actions

Import refusals

FDA data resources

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