FDA Inspection
Suzhou Avon Textile Co., Ltd.Suzhou Avon Textile Co., Ltd. – FDA Inspection, May 5, 2016
Record Details
This FDA Inspection record concerns Suzhou Avon Textile Co., Ltd., with an inspection on May 5, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 5, 2016
- Product Type
- Devices
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ID · f9ff1de9-8125-4db7-8101-b4291f3ff017
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 971368
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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