FDA Inspection
Ningbo Luke Medical Devices Co., Ltd.Ningbo Luke Medical Devices Co., Ltd. – FDA Inspection, Sep 5, 2019
Record Details
This FDA Inspection record concerns Ningbo Luke Medical Devices Co., Ltd., with an inspection on September 5, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 70b67696-6ee3-47a6-9939-5f48a20f381e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101816
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.17Lack of Written MDR Procedures
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