08.24.17
CordenPharma said that CordenPharma Latina, located near Sermoneta, Italy, has received news that the U.S.-FDA warning letter previously received has been closed, with a closeout date of August 15, 2017. The company said this is the result of a holistic and systematic approach to remediate the observations throughout the facility.
Since inception, the company said its corporate compliance team has developed a company-wide strategic approach to enhancing all quality and compliance systems by systematically reviewing and assessing each CordenPharma facility and establishing harmonization programs, knowledge management and sharing of best practices. In order to ensure effectiveness, CordenPharma has planned a long-term high investment program in regards to corporate and quality systems, organizational structure and infrastructure, including a process to involve customers in improving transparency.
Since inception, the company said its corporate compliance team has developed a company-wide strategic approach to enhancing all quality and compliance systems by systematically reviewing and assessing each CordenPharma facility and establishing harmonization programs, knowledge management and sharing of best practices. In order to ensure effectiveness, CordenPharma has planned a long-term high investment program in regards to corporate and quality systems, organizational structure and infrastructure, including a process to involve customers in improving transparency.