Company
United StatesArkray Factory USA, Inc., Doral, FL – FDA Inspections
Inspection records and compliance data for Arkray Factory USA, Inc. in Doral, Florida. 3 FDA inspections on record, last inspected August 16, 2016.
Company Profile
This profile covers Arkray Factory USA, Inc. based in Doral, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected July 22, 2011. Last inspected August 16, 2016.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 16, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 982478 |
| October 16, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 802435 |
| July 22, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 736527 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Arkray Factory USA, Inc.
FEI Number
1832816
Address
10305 Nw 41st St, Doral, Florida 33178, United States
Country
United States
ID: 93ee4304-e289-4360-b1cb-8c41e3dc446e