FDA Inspection
Jiangsu Xinbei Electrical Appliance Co., LTD.Jiangsu Xinbei Electrical Appliance Co., LTD. – FDA Inspection, Nov 9, 2023
Record Details
This FDA Inspection record concerns Jiangsu Xinbei Electrical Appliance Co., LTD., with an inspection on November 9, 2023, issued by the Office of Inspections and Investigations.
- Inspection Date
- November 9, 2023
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ID · 303b9468-da9f-4d4c-89a5-b719788d113a
Inspection Facts
- Inspection number
- 1223666
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Jiangsu Xinbei Electrical Appliance Co., LTD.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2026 | Not classified | Office of Inspections and Investigations | |
| January 18, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Jiangsu Xinbei Electrical Appliance Co., LTD.
- FDA Inspection 1317522 - 2026-04-16
- FDA Inspection 1039965 - 2018-01-18
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