FDA Inspection
GE Vingmed Ultrasound AsGE Vingmed Ultrasound As – FDA Inspection, Oct 26, 2023
Record Details
This FDA Inspection record concerns GE Vingmed Ultrasound As, with an inspection on October 26, 2023, issued by the Office of Inspections and Investigations.
- Company
- GE Vingmed Ultrasound As
- Inspection Date
- October 26, 2023
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ID · 0944a6ac-db00-4e81-8b88-4e3e35786d66
Inspection Facts
- Inspection number
- 1221565
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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