FDA Inspection
MIANYANG MEIKE ELECTRONIC EQUIPMENT CO.,LTD.MIANYANG MEIKE ELECTRONIC EQUIPMENT CO.,LTD. – FDA Inspection, Jun 8, 2017
Record Details
This FDA Inspection record concerns MIANYANG MEIKE ELECTRONIC EQUIPMENT CO.,LTD., with an inspection on June 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 51d1adb7-1c86-4e30-a139-4e5a733baf8a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016645
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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