FDA Inspection
Tomy International Inc.Tomy International Inc. – FDA Inspection, Nov 26, 2013
Record Details
This FDA Inspection record concerns Tomy International Inc., with an inspection on November 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tomy International Inc.
- Inspection Date
- November 26, 2013
- Product Type
- Devices
View Company Profile
ID · f9dcc3db-cbff-400a-bc52-5dc936f4ae19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857107
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 |
| July 15, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tomy International Inc.
- FDA Inspection 1114928 - 2020-01-13
- FDA Inspection 734866 - 2011-07-15
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