Company
Korea (the Republic of)DRGEM Corporation (Gumi Factory), Gumi, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for DRGEM Corporation (Gumi Factory) in Gumi. 1 FDA inspection on record, 1 Form 483, last inspected March 03, 2017.
Company Profile
This profile covers DRGEM Corporation (Gumi Factory) based in Gumi, 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 3, 2017.
Most cited issue areas
- Basis for selecting methods, devices, procedures1 inspection
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Compliance measurement1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 3, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1008517 |
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
DRGEM Corporation (Gumi Factory)
FEI Number
3013095958
Address
116-59 Sanhodae-Ro, Gumi, Korea (the Republic of)
Country
Korea (the Republic of)
ID: eab01124-53e0-4ed2-bc51-d1936c720f7e