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.
Most cited: 21 CFR 211.67(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Records are not kept for the maintenance…
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?
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.