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Gambro Lundia AB — FDA Facility Profile

FEI 3002807039

Gambro Lundia AB is an FDA-inspected facility (FEI 3002807039) located in Lund, SE. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 26, 2017: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 NAI)
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
4

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
Jan 26, 2017No Action Indicated (NAI)No citations listed
Dec 18, 2014Voluntary Action Indicated (VAI)No citations listed
Mar 5, 2009No Action Indicated (NAI)No citations listed

Facility details

Company
Gambro Lundia AB
Location
Lund (SE)
Source
inspections

Import refusals

FDA data resources

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