FDA Inspection
Paro Robots U.S., Inc.Paro Robots U.S., Inc. – FDA Inspection, Jun 25, 2013
Record Details
This FDA Inspection record concerns Paro Robots U.S., Inc., with an inspection on June 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Paro Robots U.S., Inc.
- Inspection Date
- June 25, 2013
- Product Type
- Devices
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ID · f4cc721d-c612-4a2a-9af0-b16d5da874c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837529
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
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Other FDA inspections of Paro Robots U.S., Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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