GlaxoSmithKline Biologicals SA
Form 483 issued February 27, 2026
- Inspection
- Feb 9 – Feb 27, 2026
- Observations
- 6
- Pages
- 10
- FEI number
- 3003973577
In short: On February 27, 2026, FDA issued a Form 483 with 6 observations to GlaxoSmithKline Biologicals SA (FEI 3003973577) after an inspection that ran Feb 9 – Feb 27, 2026. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
4 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Input to and output from the computer and related systems of formulas are…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Deviations from written production and process control…
This inspection in context
Questions about this 483
What did FDA find at GlaxoSmithKline Biologicals SA?
FDA listed 6 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was GlaxoSmithKline Biologicals SA inspected by FDA?
The inspection ran Feb 9 – Feb 27, 2026, and the Form 483 is dated February 27, 2026.
How do I get the full Form 483 for GlaxoSmithKline Biologicals SA?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.