FDA Inspection
4QImaging, LLC DBA Qmetrics4QImaging, LLC DBA Qmetrics – FDA Inspection, Feb 4, 2019
Record Details
This FDA Inspection record concerns 4QImaging, LLC DBA Qmetrics, with an inspection on February 4, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 75d19c84-e919-4b55-8a6c-664f6e47aa9b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078545
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of 4QImaging, LLC DBA Qmetrics
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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