FDA Inspection
ITO CO., LTD.ITO CO., LTD. – FDA Inspection, Sep 1, 2016
Record Details
This FDA Inspection record concerns ITO CO., LTD., with an inspection on September 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ITO CO., LTD.
- Inspection Date
- September 1, 2016
- Product Type
- Devices
View Company Profile
ID · c7b183da-ca12-4f11-94a2-94df335a0cc9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987017
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(i)Software validation for automated processes
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