Company
JapanDKK Dai-Ichi Shomei Co., Ltd., Itabashi, Japan – FDA Inspections
Inspection records and compliance data for DKK Dai-Ichi Shomei Co., Ltd. in Itabashi. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 20, 2018.
Company Profile
This profile covers DKK Dai-Ichi Shomei Co., Ltd. based in Itabashi, Japan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 1, 2014. Last inspected July 20, 2018.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- DHR content1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1062324 |
| May 1, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 879170 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DKK Dai-Ichi Shomei Co., Ltd.
FEI Number
3006437518
Address
1 Chome 32-26, Sakashita, Itabashi, Japan
Country
Japan
ID: e58c568f-a6e8-4d82-a02f-1bd9cbcd66ab