FDA EIR - Novacyl - February 02, 2018

An FDA routine cGMP surveillance inspection was conducted at Novacyl's Saint-Fons, France facility from January 29 to February 2, 2018. This inspection, guided by Compliance Programs for Active Pharmaceutical Ingredients (API) and Animal Drug Manufacturing, and ICH Q7 guidelines, covered key operational systems including Quality, Materials, Equipment, Production, Packaging, and Laboratory Control. The current inspection resulted in no formal observations documented on a Form FDA 483. However, previous deficiencies from a June 2015 inspection, classified as Voluntary Action Indicated (VAI), were reviewed. These included the absence of identity testing for incoming raw materials, inadequate data integrity controls for analytical instruments (lack of backup, unauthorized access, data alteration protection), and incomplete system suitability testing during HPLC analysis. Novacyl demonstrated corrective actions for these prior issues. Identity testing for raw materials is now performed before use, analytical instrument software was upgraded with robust data security features, and the system suitability testing was updated to comply with USP <621>. During the 2018 inspection, two minor procedural inconsistencies were identified regarding HPLC system suitability and particle size distribution test amplitude, both of which Novacyl rectified promptly during the inspection period. Management was also encouraged to enhance the facility's external appearance. The FDA stressed that non-compliance with US regulations could lead to import denial, reminding the firm of its responsibility to apply inspection learnings across all operations.