FDA Inspection 1261807 — GEMSS HEALTHCARE CO., LTD.
The FDA completed an inspection of GEMSS HEALTHCARE CO., LTD. on Feb 6, 2025 in Paju. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 6, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Paju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |