FDA Inspection 1035368 — GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC

GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC — FEI 3002183074

The FDA completed an inspection of GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC on Dec 6, 2017 in Noblesville, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 6, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Noblesville, IN (United States)

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
326321 CFR 820.250(b)Sampling plans