Company
Korea (the Republic of)Caregen Co., Ltd., Gunpo, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Caregen Co., Ltd. in Gunpo. 1 FDA inspection on record, 1 Form 483, last inspected June 29, 2018.
Company Profile
This profile covers Caregen Co., Ltd. based in Gunpo, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected June 29, 2018.
Most cited issue areas
- Backup data not assured as exact and complete1 inspection
- Microbiological Contamination Exam1 inspection
- Procedures not in writing, fully followed1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 29, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1058289 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Caregen Co., Ltd.
FEI Number
3010592110
Address
270 Gongdan-Ro, Gunpo, Korea (the Republic of)
Country
Korea (the Republic of)
ID: bb1a0061-2b9e-4bb6-867d-f2a4bed536f5