Company
United StatesTomy International Inc., Canton, MA – FDA Inspections
Inspection records and compliance data for Tomy International Inc. in Canton, Massachusetts. 3 FDA inspections on record, last inspected January 13, 2020.
Company Profile
This profile covers Tomy International Inc. based in Canton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 15, 2011. Last inspected January 13, 2020.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate2 inspections
- Design history file1 inspection
- Info evaluated to determine if event was reportable1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 13, 2020 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1114928 |
| November 26, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 857107 |
| July 15, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 734866 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Tomy International Inc.
FEI Number
1217805
Address
45 Shawmut Rd Fl 3, Canton, Massachusetts 02021, United States
Country
United States
ID: 80d50d89-e122-4dee-9bd7-298570daac92