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GAMBRO DIALYSATOREN GMBH — FDA Facility Profile

FEI 3002807035

GAMBRO DIALYSATOREN GMBH is an FDA-registered facility (FEI 3002807035) located in HECHINGEN Baden-Wurttemberg, DE. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
May 7, 2009: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
May 7, 2009
Warning letters
1 listed by FDA for this FEI, latest Sep 4, 2009
Import refusals
3

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
May 7, 2009Official Action Indicated (OAI)No citations listed

Facility details

Company
Gambro Dialysatoren GmbH
Location
HECHINGEN 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.