FDA 483 - Nitto Avecia Pharma Services, Inc. - January 24, 2020

An FDA inspection of Nitto Avecia Pharma Services, Inc. in Irvine, CA, a contract testing laboratory, revealed significant deficiencies in laboratory controls. The firm's electronic data systems lacked adequate security to prevent unauthorized modification or deletion of raw data files, and procedures for audit trail review were insufficient. This indicates a serious concern regarding data integrity and the reliability of analytical results.