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FDA Inspection
•D E Hokanson Inc•February 7, 2018

D E Hokanson Inc – FDA Inspection, Feb 7, 2018

Record Details

This FDA Inspection record concerns D E Hokanson Inc, with an inspection on February 7, 2018, issued by the Center for Devices and Radiological Health, covering devices.

Company
D E Hokanson Inc
Inspection Date
February 7, 2018
Product Type
Devices
Office
Center for Devices and Radiological Health
People
  • Christopher S. Genther (Company Rep)
  • Paul M. Kawamoto (Company Rep)
View Company Profile

ID · e924555d-8e4f-4689-b03f-5e60c5eeb986

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1040113
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  2. 21 CFR 820.40Procedures not adequately established or maintained
  3. 21 CFR 820.50(a)(1)Documented evaluation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of D E Hokanson Inc

4
DateClassificationOfficeProject area
March 19, 2015VAICenter for Devices and Radiological HealthCompliance: Devices
October 30, 2012NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
December 21, 2010VAICenter for Devices and Radiological HealthCompliance: Devices
May 8, 2009VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for D E Hokanson Inc
  • FDA Inspection 918525 - 2015-03-19
  • FDA Inspection 804776 - 2012-10-30
  • FDA Inspection 703422 - 2010-12-21
  • FDA Inspection 584834 - 2009-05-08

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