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 · cf34fbbc-90f7-4c51-96ce-267b4d83c074
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 891248
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: 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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