FDA Inspection
Foshan Gaunying Electronics Co., LtdFoshan Gaunying Electronics Co., Ltd – FDA Inspection, Nov 16, 2023
Record Details
This FDA Inspection record concerns Foshan Gaunying Electronics Co., Ltd, with an inspection on November 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d7b0e9c9-65ed-4c6f-ab99-04e6bc223c6b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223667
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Foshan Gaunying Electronics Co., Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2026 | Not classified | Office of Inspections and Investigations | |
| November 20, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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