Company
Korea (the Republic of)I-Sens, Inc., Seoul, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for I-Sens, Inc. in Seoul. 1 FDA inspection on record, last inspected February 12, 2014.
Company Profile
This profile covers I-Sens, Inc. based in Seoul, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected February 12, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 12, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 868284 |
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
I-Sens, Inc.
FEI Number
3005621222
Address
Gil, Seocho, 28 43, Banpo-Daero, Seoul, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 6d72d25b-5e33-4145-957c-8998383ae518