Company
United StatesParo Robots U.S., Inc., Itasca, IL – FDA Inspections
Inspection records and compliance data for Paro Robots U.S., Inc. in Itasca, Illinois. 2 FDA inspections on record, 1 Form 483, last inspected November 02, 2016.
Company Profile
This profile covers Paro Robots U.S., Inc. based in Itasca, Illinois, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected June 25, 2013. Last inspected November 2, 2016.
Most cited issue areas
- Complaints1 inspection
- Lack of Written MDR Procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 2, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 995333 |
| June 25, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 837529 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Paro Robots U.S., Inc.
FEI Number
3009118691
Address
150 E Pierce Rd Ste 550, Itasca, Illinois 60143, United States
Country
United States
ID: 7acb4002-660f-4d56-b39a-60032596898d