CELLTRION Inc
Form 483 issued February 27, 2024 · Incheon, South Korea
- Inspection
- Feb 19 – Feb 27, 2024
- Investigators
- Ralph M. Bernstein· Saleem A. Akhtar
- Observations
- 10
- Pages
- 26
- FEI number
- 3005241015
In short: On February 27, 2024, FDA issued a Form 483 with 10 observations to CELLTRION Inc in Incheon, South Korea (FEI 3005241015) after an inspection that ran Feb 19 – Feb 27, 2024. The investigators were Ralph M. Bernstein and Saleem A. Akhtar. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.113 (2×) · 211.160 (2×)
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 did not include…
- 02
Your firm’s biosafety testing laboratory operation is not adequately designed to support the safety, effectiveness, and…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
The responsibilities and procedures pertaining to the Quality Unit are not in…
This inspection in context
Ralph M. Bernstein
10 documents · 2019–2025
Cites 211.100 (written procedures; deviations) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CELLTRION Inc?
FDA listed 10 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected CELLTRION Inc?
Ralph M. Bernstein and Saleem A. Akhtar are named on this Form 483, for the inspection of Feb 19 – Feb 27, 2024. Each investigator has a profile showing what they cite most.
When was CELLTRION Inc inspected by FDA?
The inspection ran Feb 19 – Feb 27, 2024, and the Form 483 is dated February 27, 2024.
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.