FDA Inspection
ARKRAY, Inc.ARKRAY, Inc. – FDA Inspection, Oct 10, 2014
Record Details
This FDA Inspection record concerns ARKRAY, Inc., with an inspection on October 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ARKRAY, Inc.
- Inspection Date
- October 10, 2014
- Product Type
- Devices
View Company Profile
ID · efa66475-7602-4637-93c4-aea8a6be6653
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 902883
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of ARKRAY, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 9, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ARKRAY, Inc.
- FDA Inspection 742939 - 2011-08-02
- FDA Inspection 568755 - 2009-02-09
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