FDA Inspection
Arkray Factory USA, Inc.Arkray Factory USA, Inc. – FDA Inspection, Jul 22, 2011
Record Details
This FDA Inspection record concerns Arkray Factory USA, Inc., with an inspection on July 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arkray Factory USA, Inc.
- Inspection Date
- July 22, 2011
- Product Type
- Devices
View Company Profile
ID · f9fdae6f-5525-4d85-9070-8b67209c91ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 736527
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Arkray Factory USA, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 16, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arkray Factory USA, Inc.
- FDA Inspection 982478 - 2016-08-16
- FDA Inspection 802435 - 2012-10-16
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