GlaxoSmithKline Biologicals

Form 483 issued September 13, 2022 · Saint-Amand Les Eaux, France

Observations
1
Pages
3
FEI number
3014752610

In short: On September 13, 2022, FDA issued a Form 483 with 1 observation to GlaxoSmithKline Biologicals in Saint-Amand Les Eaux, France (FEI 3014752610). Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

1 of 1 observations on this 483 concern facilities & equipment.

Facilities & equipment1

Most cited: 21 CFR 211.67(c) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Records are not kept for the maintenance…

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This inspection in context

Questions about this 483

What did FDA find at GlaxoSmithKline Biologicals?

FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

When was GlaxoSmithKline Biologicals inspected by FDA?

This Form 483 is dated September 13, 2022.

How do I get the full Form 483 for GlaxoSmithKline Biologicals?

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