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GlaxoSmithKline Biologicals SA FDA Inspection Record

FEI 3003973577 · Inspections, Form 483s, warning letters and import refusals

GlaxoSmithKline Biologicals SA is an FDA-registered facility (FEI 3003973577) located in Wavre, BE. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE.

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What FDA found at this site

Inspections on record
None in FDA's published inspection data
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.

Form 483s and inspection documents

  • 483 on FDA.gov
    FDA listing date Feb 27, 2026, which is not always the inspection or issue date. Published by FDA Oct 20, 2026.

Facility details

Location
Wavre (BE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
decrs

FDA data resources

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