Company
Korea (the Republic of)ALPINION MEDICAL SYSTEMS CO. LTD, Dongan, Anyang, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for ALPINION MEDICAL SYSTEMS CO. LTD in Dongan, Anyang. 2 FDA inspections on record, 1 Form 483, last inspected April 06, 2017.
Company Profile
This profile covers ALPINION MEDICAL SYSTEMS CO. LTD based in Dongan, Anyang, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 15, 2013. Last inspected April 6, 2017.
Most cited issue areas
- Lack of or inadequate receiving acceptance procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 6, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1023466 |
| March 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 825909 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ALPINION MEDICAL SYSTEMS CO. LTD
FEI Number
3008950127
Address
5 Fl, I Dong, 77, Heungan-Daero 81beon-Gil, Dongan, Anyang, Korea (the Republic of)
Country
Korea (the Republic of)
ID: b862ef94-085b-4045-b584-d6b813bf1167