FDA Inspection
Wondfo USA Co LtdWondfo USA Co Ltd – FDA Inspection, May 11, 2018
Record Details
This FDA Inspection record concerns Wondfo USA Co Ltd, with an inspection on May 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a858a3a4-b91e-4983-b9bd-0c58a9c22aac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052173
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.25(a)Personnel
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.40(a)Document review procedures, designated individual
- 21 CFR 803.17Lack of Written MDR Procedures
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