FDA 483 - Nitto Avecia Pharma Services, Inc. - September 18, 2023

An FDA inspection of Nitto Avecia Pharma Services, Inc. in Irvine, CA, a drug testing facility, identified two significant observations. The firm failed to adequately investigate out-of-specification results, specifically regarding repeated system suitability failures in residual solvent testing. Additionally, the firm did not follow proper change control procedures for GMP relevant changes, such as altering drug substance specifications without initiating required change controls.