FDA Inspection
P-Ryton CorpP-Ryton Corp – FDA Inspection, Jun 10, 2011
Record Details
This FDA Inspection record concerns P-Ryton Corp, with an inspection on June 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- P-Ryton Corp
- Inspection Date
- June 10, 2011
- Product Type
- Devices
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ID · 4cffe406-2a43-461b-99d0-40c9e2917e89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 729278
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of P-Ryton Corp
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 6, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 1, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for P-Ryton Corp
- FDA Inspection 919338 - 2015-03-24
- FDA Inspection 809812 - 2012-12-06
- FDA Inspection 571849 - 2009-04-01
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