GlaxoSmithKline Vaccines Srl
Form 483 issued January 26, 2024 · Sovicille, Italy
- Inspection
- Jan 8 – Jan 26, 2024
- Investigators
- Biologics X. Ante· Ravis Radley
- Observations
- 5
- Pages
- 9
- FEI number
- 3006738517
In short: On January 26, 2024, FDA issued a Form 483 with 5 observations to GlaxoSmithKline Vaccines Srl in Sovicille, Rosia (FEI 3006738517) after an inspection that ran Jan 8 – Jan 26, 2024. The investigators were Biologics X. Ante and Ravis Radley. Most observations concern quality system and laboratory controls.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 04
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
This inspection in context
Biologics X. Ante
1 document · 2024
Cites 211.160(a) (general requirements) more than any other section. Most of their documents are for sites in Italy.
The firmGlaxoSmithKline Vaccines Srl history
The site's inspection history, in date order.
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 Vaccines Srl?
FDA listed 5 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected GlaxoSmithKline Vaccines Srl?
Biologics X. Ante and Ravis Radley are named on this Form 483, for the inspection of Jan 8 – Jan 26, 2024. Each investigator has a profile showing what they cite most.
When was GlaxoSmithKline Vaccines Srl inspected by FDA?
The inspection ran Jan 8 – Jan 26, 2024, and the Form 483 is dated January 26, 2024.
How do I get the full Form 483 for GlaxoSmithKline Vaccines Srl?
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.