FDA Inspection
Miami Device Solutions, LLC.Miami Device Solutions, LLC. – FDA Inspection, Oct 26, 2016
Record Details
This FDA Inspection record concerns Miami Device Solutions, LLC., with an inspection on October 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3ea099ee-532d-44e2-bcc9-a5825c147831
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 996561
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Miami Device Solutions, LLC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 15, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Miami Device Solutions, LLC.
- FDA Inspection 1243466 - 2024-05-13
- FDA Inspection 1151858 - 2021-09-16
- FDA Inspection 1106570 - 2019-10-15
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