CordenPharma International’s Latina facility received the warning letter from the US Food and Drug Administration (FDA) on May 20, 2016.
The letter was issued following a May 2015 inspection of the Sermoneta, Italy-based facility, which manufactures oral and sterile anti-infective penicillins and cephalosporins.
Today, the contract development and manufacturing organization (CDMO) has announced that the warning letter has been closed as of August 15, 2017.
“This success is the result of a holistic and systematic approach to remediate the observations throughout the facility,” the company said in a release.
Following the inspection, CordenPharma’s Corporate Compliance Team developed an approach to enhance its quality and compliance systems. According to the company, this included a systematic review and assessment of all its facilities.
Moving forward, it has planned a “long-term high investment” program that will address corporate and quality systems, organizational structure and infrastructure, and includes a process to involve customers in improving transparency.