FDA Inspection
GEMSS HEALTHCARE CO., LTD.GEMSS HEALTHCARE CO., LTD. – FDA Inspection, Feb 6, 2025
Record Details
This FDA Inspection record concerns GEMSS HEALTHCARE CO., LTD., with an inspection on February 6, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- GEMSS HEALTHCARE CO., LTD.
- Inspection Date
- February 6, 2025
- Product Type
- Medical Devices & Rad Health
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ID · d5402b01-4477-47f0-bec4-c6cb3b593a4f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1261807
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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