CordenPharma International received a Warning Letter received from the US Food and Drug Administration on May 24, 2016 in its CordenPharma Latina facility in Sermoneta, Italy. This action follows an earlier inspection of the site by the agency in May 2015.

“This matter is being considered throughout the organization with the utmost sense of urgency,” said the company in a statement. “CordenPharma takes quality and compliance matters seriously and stands by its commitment to fully comply with cGMP quality standards across all facilities. CordenPharma Latina will respond with a comprehensive plan to address these observations within the stipulated time-frame of 15 days. The supply of any APIs and finished dosage forms from CordenPharma Latina to its customers will not be affected by this letter.”

The FDA cited the company for good manufacturing practice violations for active pharmaceutical ingredient and finished drug product manufacturing. Specifically, the agency 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.

Source: CordenPharma and FDA