FDA Inspection
MEDIKAN CO., LTD.MEDIKAN CO., LTD. – FDA Inspection, Aug 14, 2014
Record Details
This FDA Inspection record concerns MEDIKAN CO., LTD., with an inspection on August 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- MEDIKAN CO., LTD.
- Inspection Date
- August 14, 2014
- Product Type
- Devices
View Company Profile
ID · a989b3b6-6bce-4d2b-abac-e51694b9745e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 893877
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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