FDA Inspection
DKK Dai-Ichi Shomei Co., Ltd.DKK Dai-Ichi Shomei Co., Ltd. – FDA Inspection, Jul 20, 2018
Record Details
This FDA Inspection record concerns DKK Dai-Ichi Shomei Co., Ltd., with an inspection on July 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 89d15e35-8cb6-43ec-bb66-8a48a11bc54a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1062324
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of DKK Dai-Ichi Shomei Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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