FDA 483 - Olon SPA - June 05, 2017

An FDA inspection of Capua BioServices SpA, an API manufacturer, revealed significant deficiencies in the design and monitoring of its water distribution system. The firm failed to adequately prevent contamination of drug substances due to issues with routine monitoring, sampling, testing, and identification of microbial growth. These findings indicate a lack of control over a critical utility used in drug substance production.