FDA Inspection
A&E NICE MACHINERY INDUSTRY CO., LTD. NAN YI SHYTH CO., LTDA&E NICE MACHINERY INDUSTRY CO., LTD. NAN YI SHYTH CO., LTD – FDA Inspection, Nov 5, 2015
Record Details
This FDA Inspection record concerns A&E NICE MACHINERY INDUSTRY CO., LTD. NAN YI SHYTH CO., LTD, with an inspection on November 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 5, 2015
- Product Type
- Devices
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ID · 5be1ff0f-cc69-4fd4-b00f-5804bb28ceff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954643
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.86Acceptance status
- 21 CFR 803.17Lack of Written MDR Procedures
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