Company
Korea (the Republic of)Ecotron Co. Ltd., Seoul, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Ecotron Co. Ltd. in Seoul. 1 FDA inspection on record, 1 Form 483, last inspected March 31, 2017.
Company Profile
This profile covers Ecotron Co. Ltd. based in Seoul, 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 31, 2017.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design validation - software validation not performed1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 31, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1007705 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ecotron Co. Ltd.
FEI Number
3011491794
Address
4F & 5F, Hanshin IT Tower II, 47,, Digital-Ro 9-Gil, Geumcheon-Gu, Seoul, Korea (the Republic of)
Country
Korea (the Republic of)
ID: e79f99f3-f31e-46d5-93f8-594ed582e71d