GlaxoSmithKline Biologicals
Form 483 issued March 12, 2024 · Saint-Amand Les Eaux, France
- Inspection
- Mar 4 – Mar 12, 2024
- Investigator
- Latorie S. Jones
- Observations
- 3
- Pages
- 6
- FEI number
- 3014752610
In short: On March 12, 2024, FDA issued a Form 483 with 3 observations to GlaxoSmithKline Biologicals in Saint-Amand Les Eaux, France (FEI 3014752610) after an inspection that ran Mar 4 – Mar 12, 2024. The investigator was Latorie S. Jones. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
- 03
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmGlaxoSmithKline Biologicals history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GlaxoSmithKline Biologicals?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected GlaxoSmithKline Biologicals?
Latorie S. Jones is named on this Form 483, for the inspection of Mar 4 – Mar 12, 2024. Each investigator has a profile showing what they cite most.
When was GlaxoSmithKline Biologicals inspected by FDA?
The inspection ran Mar 4 – Mar 12, 2024, and the Form 483 is dated March 12, 2024.
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.