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FDA Inspection
•Tanita Corporation Of Akita Ltd.•June 7, 2017

Tanita Corporation Of Akita Ltd. – FDA Inspection, Jun 7, 2017

Record Details

This FDA Inspection record concerns Tanita Corporation Of Akita Ltd., with an inspection on June 7, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Tanita Corporation Of Akita Ltd.
Inspection Date
June 7, 2017
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Roy Baby (Company Rep)
View Company Profile

ID · ba66885c-3ab4-44b6-a4da-b41fea4c5ad1

Inspection Facts

Inspection number
1013018
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 820.184DHR content
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  3. 21 CFR 820.70(i)Software validation for automated processes
  4. 21 CFR 820.75(a)Lack of or inadequate process validation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Tanita Corporation Of Akita Ltd.

1
DateClassificationOfficeProject area
April 17, 2014NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Tanita Corporation Of Akita Ltd.
  • FDA Inspection 878906 - 2014-04-17

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