FDA 483 - Novatech S.A. - September 05, 2019

Novatech S.A., a medical device manufacturer in La Ciotat Cedex, France, was inspected by the FDA and received nine observations related to significant deficiencies in its quality system. Key issues include the lack of a complete design history file for a Class II device, inadequate procedures for non-conforming product, CAPA, complaint handling, risk analysis, process validation, supplier control, quality audits, and management review. The findings indicate a broad failure to establish and follow adequate quality system procedures.