Company
Korea (the Republic of)DMAX Co., Ltd., Dalseong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for DMAX Co., Ltd. in Dalseong. 1 FDA inspection on record, 1 Form 483, last inspected August 22, 2019.
Company Profile
This profile covers DMAX Co., Ltd. based in Dalseong, 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 August 22, 2019.
Most cited issue areas
- Change records, content1 inspection
- Design validation - simulated testing1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 22, 2019 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1101814 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DMAX Co., Ltd.
FEI Number
3008564629
Address
37-26 Dasaro71-Gil, Dasa-Eup, Dalseong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: ae744097-23be-46e7-ac23-29386d8ed293