FDA Inspection
Wuhan Strong Electronics Co LtdWuhan Strong Electronics Co Ltd – FDA Inspection, Aug 24, 2017
Record Details
This FDA Inspection record concerns Wuhan Strong Electronics Co Ltd, with an inspection on August 24, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- August 24, 2017
- Product Type
- Medical Devices & Rad Health
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ID · 41d676c0-7eb1-4648-80c1-fe2c56789779
Inspection Facts
- Inspection number
- 1024823
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Wuhan Strong Electronics Co Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wuhan Strong Electronics Co Ltd
- FDA Inspection 889144 - 2014-07-24
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