FDA 483 - Companion Medical, Inc. - August 14, 2019

Companion Medical, Inc., a medical device manufacturer in San Diego, CA, received a Form 483 for significant quality system deficiencies during an FDA inspection. Observations included inadequate corrective and preventive action procedures, failure to follow procedures for nonconforming product disposition, and a complete lack of Device Master Records for its Class II medical devices. These issues indicate a systemic breakdown in maintaining essential quality system controls.