CELLTRION Inc
Form 483 issued June 3, 2022 · Incheon, South Korea
- Inspection
- May 23 – Jun 3, 2022
- Investigators
- Junho Pak· Ralph M. Bernstein· Wayne Seifert
- Observations
- 7
- Pages
- 6
- FEI number
- 3005241015
In short: On June 3, 2022, FDA issued a Form 483 with 7 observations to CELLTRION Inc in Incheon, Republic of (FEI 3005241015) after an inspection that ran May 23 – Jun 3, 2022. The investigators were Junho Pak, Ralph M. Bernstein and Wayne Seifert. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
5 of 7 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Failure to establish process controls designed to assure that the drug product you manufacture has the…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Deviations from written production and process control procedures are not always…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CELLTRION Inc?
FDA listed 7 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected CELLTRION Inc?
Junho Pak, Ralph M. Bernstein and Wayne Seifert are named on this Form 483, for the inspection of May 23 – Jun 3, 2022. Each investigator has a profile showing what they cite most.
When was CELLTRION Inc inspected by FDA?
The inspection ran May 23 – Jun 3, 2022, and the Form 483 is dated June 3, 2022.
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.