Company
Korea (the Republic of)DRGEM CORPORATION, Gwangmyeong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for DRGEM CORPORATION in Gwangmyeong. 2 FDA inspections on record, 1 Form 483, last inspected February 24, 2017.
Company Profile
This profile covers DRGEM CORPORATION based in Gwangmyeong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 24, 2013. Last inspected February 24, 2017.
Most cited issue areas
- Design plans - Lack of or inadequate1 inspection
- Failure to submit1 inspection
- Lack of procedures, or not maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 24, 2017 | Not classified | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1009736 |
| April 24, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 828858 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DRGEM CORPORATION
FEI Number
3006551157
Address
7F, E-B/D Gwangmyeong Techno-Park, 60 Haan-ro, Gwangmyeong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 9d1396cb-e386-4523-95de-086d0cd57d82