FDA 483 - Spok, Inc. - April 29, 2022

An FDA inspection of Spok, Inc., a medical device manufacturer in Alexandria, VA, revealed significant deficiencies across its quality management system. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, design control, management review, quality audits, and document control. Additionally, Spok, Inc. did not appoint a management representative to oversee its quality system.