Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3008322822.
Observations2
Issue DateJanuary 31, 2025
StatusWarning Letter Issued
Establishment TypeLicensed Biological Drug Manufacturer
Related Inspections3
Establishment Details
Firm
GlaxoSmithKline Biologicals Kft.
Location
Godollo, Hungary
FEI Number
3008322822
Establishment Type
Licensed Biological Drug Manufacturer
Product Type
Biologics
Issue Date
January 31, 2025
Country
Hungary
Inspection History, 2015 to 2025
NAI1
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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