FDA 483 - kdc/one Chatsworth, Inc. - May 25, 2018

An FDA inspection of Knowlton Development Company dba Thibiant International, Inc., a contract manufacturer in Chatsworth, CA, revealed significant deficiencies across its quality, facilities, laboratory, and production systems. Observations included an inadequate quality control unit, insufficient employee training, and a lack of established control procedures for water manufacturing. The firm also failed to adequately validate cleaning procedures, laboratory test methods, and equipment revalidation, alongside issues with raw material testing and electronic data retention.