Form FDA 483 · Issued 2026-02-27
GlaxoSmithKline Biologicals SA — FDA Form 483 Analysis
FEI: 3003973577 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Vaccine Manufacturer) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to GlaxoSmithKline Biologicals SA (FEI 3003973577) on 2026-02-27 following an inspection of its vaccine manufacturer operations in Belgium. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Establishment of calibration procedures
Inspector Observation Language: "Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed]. Specifically, observed during inspection of GlaxoSmithKline Biologicals SA on 2026-02-27."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #2 · 21 CFR 211.194(a)(1)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Sample identification and other information
Inspector Observation Language: "Laboratory records do not include [a description of the sample received for testing] [the source or location from where the sample was obtained] [the quantity of the sample] [the lot number or other distinctive code of the sample] [the date the sample was taken] [the date the sample was received for testing]. Specifically, observed during inspection of GlaxoSmithKline Biologicals SA on 2026-02-27."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #3 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Exposed to lower quality air/ISO 5
Inspector Observation Language: "[Sterile drugs] [Materials] were exposed to lower than ISO 5 quality air. Specifically, observed during inspection of GlaxoSmithKline Biologicals SA on 2026-02-27."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.