FDA Inspection
Taizhou Honod Medical Co. Ltd.Taizhou Honod Medical Co. Ltd. – FDA Inspection, Jun 20, 2024
Record Details
This FDA Inspection record concerns Taizhou Honod Medical Co. Ltd., with an inspection on June 20, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5776f01c-d29c-46ac-a80d-4824cfeebdcc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1243634
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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