Company
Korea (the Republic of)Diotech Co. Ltd., Busan, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Diotech Co. Ltd. in Busan. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected July 28, 2017.
Company Profile
This profile covers Diotech Co. Ltd. based in Busan, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected July 28, 2017.
Most cited issue areas
- Certification label or tag1 inspection
- Complaints1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 28, 2017 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1020606 |
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
Diotech Co. Ltd.
FEI Number
3010969268
Address
212, Ildong-Jiaenin, Nakdongdero 301, Saha Gu, Busan, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 4a5e0b21-ac21-4f32-9ef2-85dddc07098e