FDA Inspection
EMcision Ltd.FDA Inspection 891248 - EMcision Ltd. - August 14, 2014
Record Details
This FDA Inspection record concerns EMcision Ltd., with an inspection on August 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EMcision Ltd.
- Inspection Date
- August 14, 2014
- Product Type
- Devices
View Company Profile
ID · 34a43cd7-9c55-4a7f-9454-6788ca9b1ec8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891248
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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