FDA EIR - Nitto Avecia Pharma Services, Inc. - September 06, 2019

Nitto Avecia Pharma Services, Inc., a Contract Development and Manufacturing Organization (CDMO), underwent a surveillance inspection by the FDA from September 4-6, 2019. This inspection, conducted under Compliance Program 7371.001 for Animal Drug Manufacturing, focused on the firm's Quality, Facilities and Equipment, and Laboratory Systems. No significant deficiencies were found during this visit, and therefore, no Form FDA 483 (Inspectional Observations) was issued. However, the report also referenced a previous FDA inspection from May 20-24, 2019, which identified several critical issues. During that prior inspection, a Form FDA 483 was issued due to deficiencies including: batches not accurately reflecting the manufacturing process; failure to conduct performance qualification for a filling line before use; release of drug product batches without process validation and using an unvalidated sterility testing method; an inadequate visual inspection program with untrained personnel; incomplete production records lacking in-process sampling and testing procedures; environmental monitoring issues without media growth promotion testing; unmonitored integrity and replacement schedules for sterile product gloves; inadequate investigation of expired raw material usage; and improper management of reserve drug product samples. The September 2019 inspection did not assess the corrective actions for these earlier observations. Management was also verbally advised on three discussion items concerning change controls, a specific test analysis, and environmental temperature monitoring.