Hokanson, a Bellevue, Washington medical device manufacturer, was cited by the FDA for deficiencies regarding complaint handling, supplier evaluation and document control.
The agency issued the company a Form 483 for its complaint handling procedures, which were not adequately implemented. The firm did not have a documented review for a potential reportable event or a documented review by its president, both requirements of its complaint handling procedure.
The agency also noted that the company did not properly document its evaluation of potential suppliers, as it lacked documentation for the evaluation of a supplier that was on its approved vendor list.
In addition, the firm’s document control procedures were faulty. One supplier file included an unapproved revision of one of the firm’s supplier information forms.