Company
Korea (the Republic of)Corentec Co., LTD, Cheonan, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Corentec Co., LTD in Cheonan. 5 FDA inspections on record, 1 Form 483, last inspected August 29, 2024.
Company Profile
This profile covers Corentec Co., LTD based in Cheonan, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 16, 2014. Last inspected August 29, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Acceptance status1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 29, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1243031 |
| October 31, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1110015 |
| April 19, 2017 | Not classified | Medical Devices & Rad Health | 1009769 |
| April 9, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 924849 |
| January 16, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 867451 |
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
Corentec Co., LTD
FEI Number
3009106092
Address
Ipjang-Myeon, Seobuk, 12 Yeongsanhong1-Gil; Seobuk, Cheonan, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 729648c9-792e-4bd5-ab0a-410043c4e7d0