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GlaxoSmithKline Biologicals Kft. FDA Inspection Record

FEI 3008322822 · Inspections, Form 483s, warning letters and import refusals

GlaxoSmithKline Biologicals Kft. is an FDA-inspected facility (FEI 3008322822) located in Godollo, HU. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 31, 2025: Voluntary Action Indicated (VAI)
Inspections on record
3 (2 VAI, 1 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
Form 483 and inspection documents
1 in FDA's reading room

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 31, 2025Voluntary Action Indicated (VAI)No citations listed
Feb 13, 2023No Action Indicated (NAI)No citations listed
Oct 6, 2015Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Jan 31, 2025, which is not always the inspection or issue date. Published by FDA Oct 20, 2026.

Facility details

Company
GlaxoSmithKline Biologicals Kft.
Location
Godollo (HU)
Source
inspections

FDA data resources

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