FDA Inspection
Ningbo Makeheat Electrical Appliance Co., LTDNingbo Makeheat Electrical Appliance Co., LTD – FDA Inspection, Nov 13, 2014
Record Details
This FDA Inspection record concerns Ningbo Makeheat Electrical Appliance Co., LTD, with an inspection on November 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 13, 2014
- Product Type
- Devices
View Company Profile
ID · d34a5d45-3334-402f-ab9e-761ad170ec60
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 905891
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Ningbo Makeheat Electrical Appliance Co., LTD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2017 | Not classified | Office of Inspections and Investigations |
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