GlaxoSmithKline Biologicals Kft. FDA Record

Summary

FDA record by year

GlaxoSmithKline Biologicals Kft.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for GlaxoSmithKline Biologicals Kft. above. Glaxosmithkline is the parent company.

GlaxoSmithKline Biologicals Kft. Form 483s

1 Form 483 published by FDA.

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

3 inspections from Oct 6, 2015 to Jan 31, 2025.

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

GlaxoSmithKline Biologicals Kft. and the FDA: common questions

Has GlaxoSmithKline Biologicals Kft. received an FDA warning letter?

No FDA warning letter addressed to the name "GlaxoSmithKline Biologicals Kft." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has GlaxoSmithKline Biologicals Kft. received an FDA Form 483?

FDA has published 1 Form 483 for GlaxoSmithKline Biologicals Kft. in its reading room, the most recent dated Jan 31, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect GlaxoSmithKline Biologicals Kft.?

The most recent FDA inspection on file ended Jan 31, 2025 at Godollo, Hungary and was classified VAI. FDA has 3 inspections of GlaxoSmithKline Biologicals Kft. on file.