Company
JapanAtom Medical Corporation, Saitama, Japan – FDA Inspections
Inspection records and compliance data for Atom Medical Corporation in Saitama. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected November 10, 2017.
Company Profile
This profile covers Atom Medical Corporation based in Saitama, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 20, 2013. Last inspected November 10, 2017.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- DHR content1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 10, 2017 | Not classified | Medical Devices & Rad Health | 1085894 |
| September 20, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 851256 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Atom Medical Corporation
FEI Number
3004846435
Address
2 Chome 2-1, Dojo; Sakura, Saitama, Japan
Country
Japan
ID: 51adfd5f-bfb3-4db8-b765-fc8a51c1165c