Home / Facilities / 3003814961

COLOPLAST HUNGARY KFT — FDA Facility Profile

FEI 3003814961

COLOPLAST HUNGARY KFT is an FDA-registered facility (FEI 3003814961) located in TATABANYA Komarom-Esztergom, HU. RegDataLab tracks 2 FDA inspections at this facility.

Reviewing COLOPLAST HUNGARY KFT 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 COLOPLAST HUNGARY KFT 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

What FDA found at this site

Latest inspection
Jun 11, 2015: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 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
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
Jun 11, 2015Voluntary Action Indicated (VAI)Documentation of software validation (21 CFR 820.70(i))
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Documentation (21 CFR 820.100(b))
Jun 18, 2009Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Coloplast Hungary Kft
Location
TATABANYA Komarom-Esztergom (HU)
Source
device

Import refusals

FDA data resources

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