FDA Inspection
Kunshan Jiehong Nonwoven Product Co., Ltd.Kunshan Jiehong Nonwoven Product Co., Ltd. – FDA Inspection, Jan 23, 2014
Record Details
This FDA Inspection record concerns Kunshan Jiehong Nonwoven Product Co., Ltd., with an inspection on January 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 23, 2014
- Product Type
- Devices
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ID · 8e12624e-7580-44ac-8172-e4ee84a53b55
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868178
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.30(g)Design validation - Risk analysis
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Other FDA inspections of Kunshan Jiehong Nonwoven Product Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kunshan Jiehong Nonwoven Product Co., Ltd.
- FDA Inspection 1113686 - 2019-11-21
- FDA Inspection 1074262 - 2018-11-06
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