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GlaxoSmithKline Biologicals SA FDA Inspection Record

FEI 3002875226 · Inspections, Form 483s, warning letters and import refusals

GlaxoSmithKline Biologicals SA is an FDA-registered facility (FEI 3002875226) located in B-1330, BE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 23, 2023: No Action Indicated (NAI)
Inspections on record
5 (4 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
Recalls as the recalling firm
3, latest Oct 22, 2021
Import refusals
10 or more

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
Jun 23, 2023No Action Indicated (NAI)No citations listed
Jan 27, 2017Voluntary Action Indicated (VAI)No citations listed
Oct 2, 2014Voluntary Action Indicated (VAI)No citations listed
Oct 5, 2012Voluntary Action Indicated (VAI)No citations listed
Jun 3, 2010Voluntary Action Indicated (VAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 22, 2021Class IIIB-0049-2024Hepatitis B Vaccine (Recombinant)
Following a customer complaint received by GSK on August 4, 2021, five syringes from two different cartons (three syringes out of ten in the…
Feb 10, 2021Class IIB-0264-2022Zoster Vaccine Live
Vaccine, placed in glass vials found to have morphology defects, was distributed.
Jul 11, 2017Class IIIB-0705-2018Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate…
MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM(197) Conjugate Vaccine] Solution for intramuscular…

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Jun 24, 2019, which is not always the inspection or issue date. Published by FDA Oct 26, 2026.

Facility details

Company
GlaxoSmithKline Biologicals SA
Location
B-1330 (BE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
decrs

Import refusals

FDA data resources

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