FDA Inspection
P-Ryton CorpP-Ryton Corp – FDA Inspection, Apr 1, 2009
Record Details
This FDA Inspection record concerns P-Ryton Corp, with an inspection on April 1, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- P-Ryton Corp
- Inspection Date
- April 1, 2009
- Product Type
- Devices
View Company Profile
ID · 6e3419f8-dd33-4328-a8ff-4344bd479a4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 571849
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| June 10, 2011 | 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 729278 - 2011-06-10
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.