FDA Inspection
Rion Co., Ltd.Rion Co., Ltd. – FDA Inspection, Aug 27, 2015
Record Details
This FDA Inspection record concerns Rion Co., Ltd., with an inspection on August 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rion Co., Ltd.
- Inspection Date
- August 27, 2015
- Product Type
- Devices
View Company Profile
ID · 79ab72d4-57e6-481b-bf98-739f767c43cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943903
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Rion Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Rion Co., Ltd.
- FDA Inspection 681525 - 2010-08-26
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