FDA Inspection
Tomy International Inc.Tomy International Inc. – FDA Inspection, Jul 15, 2011
Record Details
This FDA Inspection record concerns Tomy International Inc., with an inspection on July 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tomy International Inc.
- Inspection Date
- July 15, 2011
- Product Type
- Devices
View Company Profile
ID · 83dda698-2375-4795-8e62-4112f19ccd57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734866
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tomy International Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 26, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Tomy International Inc.
- FDA Inspection 1114928 - 2020-01-13
- FDA Inspection 857107 - 2013-11-26
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