FDA Inspection
Hoveround CorporationFDA Inspection 1094811 - Hoveround Corporation - June 14, 2019
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Record Details
This FDA Inspection record concerns Hoveround Corporation, with an inspection on June 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8f34a052-6c9d-48ab-a15f-e7ccecc33204
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094811
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hoveround Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| May 23, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 25, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |