FDA Inspection
UltraRad CorporationUltraRad Corporation – FDA Inspection, Mar 5, 2009
Record Details
This FDA Inspection record concerns UltraRad Corporation, with an inspection on March 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- UltraRad Corporation
- Inspection Date
- March 5, 2009
- Product Type
- Devices
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ID · e02447b1-d0af-4506-8f07-29a61cde6dd6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 563822
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(a)(1)Analysis of data sources
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of UltraRad Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 17, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for UltraRad Corporation
- FDA Inspection 1222755 - 2023-08-18
- FDA Inspection 1021969 - 2017-08-17
- FDA Inspection 823495 - 2013-03-26
- FDA Inspection 659908 - 2010-05-10
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