FDA Inspection
Sagami Rubber Industries Co., Ltd.Sagami Rubber Industries Co., Ltd. – FDA Inspection, Feb 4, 2011
Record Details
This FDA Inspection record concerns Sagami Rubber Industries Co., Ltd., with an inspection on February 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 4, 2011
- Product Type
- Devices
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ID · 9d6fe5c1-b142-41ab-81dc-b3b79de840dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709919
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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Other FDA inspections of Sagami Rubber Industries Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2015 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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