FDA 483 - Cetro America Inc. - January 11, 2018

An FDA inspection of Cetrix America in Wallingford, CT, a specifications developer and initial importer, revealed a significant lack of established quality system procedures. The firm was cited for not having written procedures for the establishment and maintenance of a quality system, including a quality manual and procedures for corrective and preventive actions, complaint handling, and servicing. This indicates a fundamental deficiency in the firm's quality management system.