FDA Inspection 1210335 — GE Healthcare - Repair Operations Center

GE Healthcare - Repair Operations Center — FEI 3013679558

The FDA completed an inspection of GE Healthcare - Repair Operations Center on July 18, 2023 in Oak Creek, WI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 18, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Oak Creek, WI (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures