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

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.