FDA Inspection
Paro Robots U.S., Inc.Paro Robots U.S., Inc. – FDA Inspection, Nov 2, 2016
Record Details
This FDA Inspection record concerns Paro Robots U.S., Inc., with an inspection on November 2, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e1bb8469-2fbf-4794-abdb-5184a321d29f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995333
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Paro Robots U.S., Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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