CordenPharma Receives FDA OK for Mfg Facility
The US Food and Drug Administration (FDA) has closed a Warning Letter regarding CordenPharma International’s site, CordenPharma Latina, in Sermoneta, Italy. CordenPharma had received the Warning Letter in May 2016 after an earlier inspection of the site by the FDA in May 2015.
The site manufactures oral and sterile liquid dosage forms for cephalosporins, penicillins, and cytotoxics as well cephalosporin and penicillin drug substances. It also provides packaging services.
In response to the Warning Letter, CordenPharma said that its corporate compliance team developed a company-wide strategic approach to enhance all quality and compliance systems by reviewing and assessing each CordenPharma facility. This included establishing harmonization programs, knowledge management, and sharing of best practices. CordenPharma says it has planned a long-term investment program to its corporate and quality systems, organizational structure, and infrastructure, including a process to involve customers in improving transparency.
In the Warning Letter, the had FDA cited the company for good manufacturing practice violations for active pharmaceutical ingredient and finished drug product manufacturing. Specifically, the FDA cited the firm for failing to have facilities used in the manufacture, process, packaging and holding of drug products of appropriate construction to facilitate cleaning, maintenance, and proper operations. It cited cracked floor tiles in the aseptic manufacturing area. The agency also cited the firm for having stagnant water following cleaning procedures. The firm also cited the company for sampling issues and testing issues during process validation. With respect to API manufacturing, the agency cited the firm for issues in environmental monitoring and drainage in its API aseptic processing area.