Corixa Corporation d.b.a. GlaxoSmithKline
Form 483 issued March 4, 2022 · Marietta, Pennsylvania
- Inspection
- Feb 28 – Mar 4, 2022
- Investigators
- Aerse Ete Pankaj Amin· Burnell M. Henry
- Observations
- 2
- Pages
- 3
- FEI number
- 30077266770
In short: On March 4, 2022, FDA issued a Form 483 with 2 observations to Corixa Corporation d.b.a. GlaxoSmithKline in Marietta, Pennsylvania (FEI 30077266770) after an inspection that ran Feb 28 – Mar 4, 2022. The investigators were Aerse Ete Pankaj Amin and Burnell M. Henry. Most observations concern packaging & labeling and quality system; the most-cited regulation is 21 CFR 211.130 (packaging and labeling operations).
At a glance
Packaging & labeling and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.130 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inspection of the packaging facilities are deficient after use to assure that materials not suitable for…
- 02
Written records of investigations into the failure of a batch or any of its components to…
This inspection in context
Aerse Ete Pankaj Amin
1 document · 2022
Cites 211.130 (packaging and labeling operations) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCorixa Corporation d.b.a. GlaxoSmithKline history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corixa Corporation d.b.a. GlaxoSmithKline?
FDA listed 2 observations on this Form 483, mostly about packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.130 (packaging and labeling operations). The opening words of each observation are shown on this page.
Who inspected Corixa Corporation d.b.a. GlaxoSmithKline?
Aerse Ete Pankaj Amin and Burnell M. Henry are named on this Form 483, for the inspection of Feb 28 – Mar 4, 2022. Each investigator has a profile showing what they cite most.
When was Corixa Corporation d.b.a. GlaxoSmithKline inspected by FDA?
The inspection ran Feb 28 – Mar 4, 2022, and the Form 483 is dated March 4, 2022.
How do I get the full Form 483 for Corixa Corporation d.b.a. 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.