Blink Device Company, LLC – FDA 483, Oct 15, 2021

Blink Device Company, LLC, a medical device manufacturer in Seattle, WA, received a Form FDA 483 with four observations during an inspection. The firm was cited for inadequate establishment and implementation of procedures related to complaint handling, corrective and preventive actions (CAPA), design verification, and document control. These findings indicate significant deficiencies in the company's quality system.