# FDA 483 - D E Hokanson Inc - February 07, 2018

Source: https://www.keypedia.com/records/483/d-e-hokanson-inc/c4eff04e-5227-435d-98fa-586e32f463fe

> FDA 483 for D E Hokanson Inc on February 07, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: D E Hokanson Inc
- Inspection Date: 2018-02-07
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of D. E. Hokanson, Inc., a medical device manufacturer in Bellevue, WA, revealed significant deficiencies in their quality system. Observations included inadequate procedures for complaint handling, undocumented supplier evaluations, and failures in document control. These issues indicate a need for improved implementation and adherence to established quality system requirements.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)
- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.keypedia.com/companies/d-e-hokanson-inc/30d158e6-a482-477d-954b-aab0a0900228

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822