CELLTRION Inc
FDA inspection history in Incheon, South Korea, 2017 to 2024
- 4
- Form 483s
- 3
- Close-outs
- 1
- EIR
Every document, by year
- Form 483
- Close-out
- EIR
2017: one inspection report; 2018: three close-out letters and one Form 483; 2019: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Three close-out letters, two Form 483s and one inspection report, at Incheon, South Korea.
- 2022–24Two Form 483s, at Incheon, South Korea.
- 2024The longest 483 on file: 10 observations over 26 pages at Incheon, South Korea.
Cited most
Across all CELLTRION observations on file
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.42Design and construction features2
The complete CELLTRION file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Incheon, South Korea
Three Form 483s and two close-out letters · 2018 to 2024 · 18 observations
Latest: Form 483, Feb 27, 2024 →
Also: three documents not tied to a site.
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-27 | 483 Form 483 | Incheon, South Korea | 10 | $99 |
| 2022-06-03 | 483 Form 483 | Incheon, South Korea | 7 | $99 |
| 2019-10-22 | 483 Form 483 | Incheon, South Korea | 1 | $99 |
| 2018-09-17 | Close-out Close-out letter | — | — | $99 |
| 2018-09-17 | Close-out Close-out letter | Incheon, South Korea | — | $99 |
| 2018-07-17 | 483 Form 483 | — | — | $99 |
| 2018-01-26 | Close-out Close-out letter | Incheon, South Korea | — | $99 |
| 2017-06-02 | EIR EIR | — | — | $550 |
Investigators on these documents
Ralph M. Bernstein (2)Junho Pak (1)Justin A. Boyd (1)Matthew B. Casale (1)Saleem A. Akhtar (1)Wayne Seifert (1)
FEI number 3005241015 · most recent document Feb 27, 2024
About CELLTRION Inc
How many FDA Form 483s has CELLTRION Inc received?
FDA Intel has 4 Form 483s on file for CELLTRION Inc; the most recent is dated Feb 27, 2024.
When was CELLTRION Inc last inspected by FDA?
The most recent FDA inspection document on file for CELLTRION Inc is a Form 483 dated Feb 27, 2024, for the site in Incheon, South Korea.
What did FDA cite at CELLTRION Inc?
The regulations cited most in the observations on file for CELLTRION Inc are 21 CFR 211.100 (Written procedures; deviations), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.160 (General requirements), 2 times.