FDA 483 - Livongo Health, Inc. - November 28, 2018

Chicago Health, Inc., a medical device manufacturer in Chicago, IL, received a Form FDA-483 for significant quality system deficiencies. The firm failed to adequately establish procedures for ensuring purchased products and services conform to specified requirements, including issues with supplier quality agreements and review of device history records. Additionally, the company did not fully document corrective and preventive action activities related to various product defects.