CELLTRION PHARM, INC
FDA inspection history in Cheongju, South Korea, 2023 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24Two Form 483s, at Cheongju, South Korea.
- 2023The longest 483 on file: 3 observations over 45 pages at Cheongju, South Korea.
Cited most
Across all CELLTRION PHARM observations on file
- 21 CFR 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete CELLTRION PHARM file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Cheongju, South Korea
Two Form 483s · 2023 to 2024 · 6 observations
Latest: Form 483, Jul 23, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-23 | 483 Form 483 | Cheongju, South Korea | 3 | $99 |
| 2023-09-14 | 483 Form 483 | Cheongju, South Korea | 3 | $99 |
Investigators on these documents
FEI number 3012279978 · most recent document Jul 23, 2024
About CELLTRION PHARM, INC
How many FDA Form 483s has CELLTRION PHARM, INC received?
FDA Intel has 2 Form 483s on file for CELLTRION PHARM, INC; the most recent is dated Jul 23, 2024.
When was CELLTRION PHARM, INC last inspected by FDA?
The most recent FDA inspection document on file for CELLTRION PHARM, INC is a Form 483 dated Jul 23, 2024, for the site in Cheongju, South Korea.
What did FDA cite at CELLTRION PHARM, INC?
The regulations cited most in the observations on file for CELLTRION PHARM, INC are 21 CFR 803.52 (If I am a manufacturer, what information must I submit in my individual adverse event reports?), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.