FDA Inspection
DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORYDONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY – FDA Inspection, Dec 1, 2016
Record Details
This FDA Inspection record concerns DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY, with an inspection on December 1, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- December 1, 2016
- Product Type
- Medical Devices & Rad Health
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ID · 16d991a3-e017-4ed6-89dd-cc4a3454a920
Inspection Facts
- Inspection number
- 994820
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for DONGGUAN SHIN YI HEALTHCARE PRODUCTS FACTORY
- FDA Inspection 938458 - 2015-06-18
- FDA Inspection 744736 - 2011-08-11
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