FDA Inspection 1202989 — QSUM Biopsy Disposables, LLC.

QSUM Biopsy Disposables, LLC. — FEI 3005675811

The FDA completed an inspection of QSUM Biopsy Disposables, LLC. on April 11, 2023 in Baxter, MN. 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
April 11, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Baxter, MN (United States)

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures