Company
Korea (the Republic of)GEMSS HEALTHCARE CO., LTD., Paju, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for GEMSS HEALTHCARE CO., LTD. in Paju. 1 FDA inspection on record, 1 Form 483, last inspected February 06, 2025.
Company Profile
This profile covers GEMSS HEALTHCARE CO., LTD. based in Paju, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected February 6, 2025.
Most cited issue areas
- Certification not based on adequate test/testing program1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 6, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1261807 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GEMSS HEALTHCARE CO., LTD.
FEI Number
3030089787
Address
1f 822, Bogwang-Ro, Gwangtan-Myeon, Paju, Korea (the Republic of)
Country
Korea (the Republic of)
ID: e877be4e-787e-422f-9145-f4d4b60eb9bb