FDA Inspection
Denka Co. Ltd.Denka Co. Ltd. – FDA Inspection, Jul 6, 2017
Record Details
This FDA Inspection record concerns Denka Co. Ltd., with an inspection on July 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 92f152f2-65f4-440b-91b2-ef347d4cdd69
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1022352
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(c)Design input - documentation
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Other FDA inspections of Denka Co. Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Denka Co. Ltd.
- FDA Inspection 1241642 - 2024-05-23
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