FDA Inspection
SHUN HO INDUSTRIAL LTD./Shun Sze Industrial (Shenzhen Co)SHUN HO INDUSTRIAL LTD./Shun Sze Industrial (Shenzhen Co) – FDA Inspection, Nov 10, 2016
Record Details
This FDA Inspection record concerns SHUN HO INDUSTRIAL LTD./Shun Sze Industrial (Shenzhen Co), with an inspection on November 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 10, 2016
- Product Type
- Devices
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ID · bc57849b-c393-4891-a3fa-822fdd1cb463
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994063
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
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