Company
Korea (the Republic of)Dae Shin Enterprise Co., Ltd., Seoul, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Dae Shin Enterprise Co., Ltd. in Seoul. 1 FDA inspection on record, last inspected April 12, 2013.
Company Profile
This profile covers Dae Shin Enterprise Co., Ltd. based in Seoul, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected April 12, 2013.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Certification label or tag1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 12, 2013 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 834991 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Dae Shin Enterprise Co., Ltd.
FEI Number
3003152478
Address
401/402, WOOLIM EBIZ Center, 170-5 Guro Dong, Guro-Gu, Seoul, Korea (the Republic of)
Country
Korea (the Republic of)
ID: c5e5b57f-3aa2-42ca-9f80-b77c9dd9b007