FDA Inspection
QSUM Biopsy Disposables, LLC.QSUM Biopsy Disposables, LLC. – FDA Inspection, Apr 11, 2023
Record Details
This FDA Inspection record concerns QSUM Biopsy Disposables, LLC., with an inspection on April 11, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 80acf0e2-7a0b-44ec-87fd-adc49aee7ff0
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1202989
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(a)Design control - no procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of QSUM Biopsy Disposables, LLC.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for QSUM Biopsy Disposables, LLC.
- FDA Inspection 961909 - 2016-03-02
- FDA Inspection 654366 - 2010-03-26
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