GlaxoSmithKline
Form 483 issued September 25, 2024 · Conshohocken, Pennsylvania
- Inspection
- Sep 17 – Sep 25, 2024
- Investigators
- Jun Liu· Priscilla Amaral· Yi Wang
- Observations
- 5
- Pages
- 6
- FEI number
- 3004055938
In short: On September 25, 2024, FDA issued a Form 483 with 5 observations to GlaxoSmithKline in Conshohocken, Pennsylvania (FEI 3004055938) after an inspection that ran Sep 17 – Sep 25, 2024. The investigators were Jun Liu, Priscilla Amaral, Yi Wang, Zhen Ren and Zhong Li. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specifically, (Stage™® It is noted that the in-process (b) (4) DS…
- 02
Your firm has not adequately validated your manufacturing process fox(b) (4)…
- 03
Written records of investigations into unexplained discrepancies do not always include appropriate…
- 04
of the leakage. The conclusion of no microbial contamination was drawn from final bioburden release results…
This inspection in context
Jun Liu
5 documents · 2019–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
The firmGlaxoSmithKline history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at GlaxoSmithKline?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected GlaxoSmithKline?
Jun Liu, Priscilla Amaral, Yi Wang, Zhen Ren and Zhong Li are named on this Form 483, for the inspection of Sep 17 – Sep 25, 2024. Each investigator has a profile showing what they cite most.
When was GlaxoSmithKline inspected by FDA?
The inspection ran Sep 17 – Sep 25, 2024, and the Form 483 is dated September 25, 2024.
How do I get the full Form 483 for GlaxoSmithKline?
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.