Company
Korea (the Republic of)Digiray Corp, Daejeon, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Digiray Corp in Daejeon. 1 FDA inspection on record, 1 Form 483, last inspected March 16, 2017.
Company Profile
This profile covers Digiray Corp based in Daejeon, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected March 16, 2017.
Most cited issue areas
- Design validation - software validation not performed1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 16, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1008523 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Digiray Corp
FEI Number
3009532935
Address
Bldg 1, 43, Munpyeongdong-ro, Daedeok-gu, Daejeon, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 17a9f856-5512-4621-9d32-84dac073215c