FDA Inspection
Shima Laboratories Co., Ltd.Shima Laboratories Co., Ltd. – FDA Inspection, Jul 28, 2016
Record Details
This FDA Inspection record concerns Shima Laboratories Co., Ltd., with an inspection on July 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Shima Laboratories Co., Ltd.
- Inspection Date
- July 28, 2016
- Product Type
- Devices
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ID · 9c0f698f-8ece-42c6-b2af-cfb6511ef04c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 988463
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.180(b)Retention period
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Other FDA inspections of Shima Laboratories Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2023 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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