Company
United StatesQSUM Biopsy Disposables, LLC., Baxter, MN – FDA Inspections
Inspection records and compliance data for QSUM Biopsy Disposables, LLC. in Baxter, Minnesota. 3 FDA inspections on record, 1 Form 483, last inspected April 11, 2023.
Company Profile
This profile covers QSUM Biopsy Disposables, LLC. based in Baxter, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 26, 2010. Last inspected April 11, 2023.
Most cited issue areas
- Design control - no procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 11, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1202989 |
| March 2, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 961909 |
| March 26, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 654366 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
QSUM Biopsy Disposables, LLC.
FEI Number
3005675811
Address
4705 Cedar Scenic Rd, Baxter, Minnesota 56425, United States
Country
United States
ID: 9ce13ac3-bfec-4733-81c8-08da185ba9a1