FDA Inspection
Mone Medikal A.S.Mone Medikal A.S. – FDA Inspection, Apr 17, 2014
Record Details
This FDA Inspection record concerns Mone Medikal A.S., with an inspection on April 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mone Medikal A.S.
- Inspection Date
- April 17, 2014
- Product Type
- Devices
View Company Profile
ID · f3a450f8-787f-4657-a56c-0e07e739d88d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 878923
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
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