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

An FDA abbreviated surveillance inspection of Nitto Avecia Pharma Services, Inc. was conducted from September 4-6, 2019. The inspection focused on the Irvine, CA facility's Quality, Facilities and Equipment, and Laboratory Systems related to its contract test laboratory operations, under the framework of animal drug manufacturing inspections (Compliance Program 7371.001). Crucially, this inspection concluded without the issuance of a Form FDA 483, Inspectional Observations, indicating no significant GMP or Quality System deficiencies were identified at that time. However, three discussion items were verbally conveyed to management. These included concerns regarding the change control process, specifically the implementation of changes before approval and incomplete asset retirement. Another item addressed the frequency of bacterial endotoxin testing for environmental samples, raising a potential risk of delayed detection for contamination. Lastly, an uninvestigated temperature excursion in a stability chamber, identified during the inspection, prompted the initiation of a Quality Incident Report (QIR) before the inspection's close. The report also referenced extensive deficiencies from a *previous* FDA inspection conducted in May 2019, where a Form FDA 483 was issued with nine observations. These prior issues covered a range of concerns, including manufacturing process documentation, equipment performance qualification, sterility testing validation, visual inspection program inadequacies, incomplete batch records, environmental monitoring procedures, and integrity monitoring for gloves used in sterile production. The September 2019 inspection did not assess the firm's corrective actions for these earlier observations.