FDA Inspection
Medica-Rents Co., Ltd.Medica-Rents Co., Ltd. – FDA Inspection, Jan 28, 2011
Record Details
This FDA Inspection record concerns Medica-Rents Co., Ltd., with an inspection on January 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medica-Rents Co., Ltd.
- Inspection Date
- January 28, 2011
- Product Type
- Devices
View Company Profile
ID · f8e862d5-78d2-4dc6-aa43-3c5eeb63aaca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708680
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - software validation not performed
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Other FDA inspections of Medica-Rents Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 25, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medica-Rents Co., Ltd.
- FDA Inspection 793367 - 2012-08-02
- FDA Inspection 751829 - 2011-10-25
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