CELLTRION Inc
Form 483 issued October 22, 2019 · Incheon, South Korea
- Inspection
- Oct 14 – Oct 22, 2019
- Investigator
- Matthew B. Casale
- Observations
- 1
- Pages
- 1
- FEI number
- 3005241015
In short: On October 22, 2019, FDA issued a Form 483 with 1 observation to CELLTRION Inc in Incheon, South Korea (FEI 3005241015) after an inspection that ran Oct 14 – Oct 22, 2019. The investigator was Matthew B. Casale. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(iii) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmCELLTRION Inc history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CELLTRION Inc?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected CELLTRION Inc?
Matthew B. Casale is named on this Form 483, for the inspection of Oct 14 – Oct 22, 2019. Each investigator has a profile showing what they cite most.
When was CELLTRION Inc inspected by FDA?
The inspection ran Oct 14 – Oct 22, 2019, and the Form 483 is dated October 22, 2019.
How do I get the full Form 483 for CELLTRION Inc?
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.