FDA Inspection
KANEKA MEDICAL VIETNAM Co.,Ltd.KANEKA MEDICAL VIETNAM Co.,Ltd. – FDA Inspection, Feb 13, 2025
Record Details
This FDA Inspection record concerns KANEKA MEDICAL VIETNAM Co.,Ltd., with an inspection on February 13, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- February 13, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 4fbd26cc-f4ed-4c3d-a1fa-9661df08b670
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1260820
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.