FDA Inspection
Lerado Zhongshan Peaceful Cove Business Trading CO., LTDLerado Zhongshan Peaceful Cove Business Trading CO., LTD – FDA Inspection, Sep 1, 2016
Record Details
This FDA Inspection record concerns Lerado Zhongshan Peaceful Cove Business Trading CO., LTD, with an inspection on September 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 1, 2016
- Product Type
- Devices
View Company Profile
ID · 8ff240c0-edee-4413-a970-f19050ae0afa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000065
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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