Company
Korea (the Republic of)Celltrion Pharm, Inc., Cheongju, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Celltrion Pharm, Inc. in Cheongju. 5 FDA inspections on record, 1 Form 483, last inspected July 23, 2024.
Company Profile
This profile covers Celltrion Pharm, Inc. based in Cheongju, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected November 17, 2017. Last inspected July 23, 2024.
Most cited issue areas
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 23, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1247299 |
| September 14, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1219108 |
| June 16, 2023 | Not classified | Human Drugs | 1209014 |
| July 12, 2019 | Not classified | Human Drugs | 1102190 |
| November 17, 2017 | Not classified | Human Drugs | 1034680 |
FDA documents
People (2)
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Company Information
Name
Celltrion Pharm, Inc.
FEI Number
3012279978
Address
82 2sandan-Ro; Cheongwon, Cheongju, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 481a4273-bf7e-4b37-8cd8-08b977ba576b