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An FDA evaluation concluded that Corden Pharma Latina’s corrective actions addressed the concerns in an FDA warning letter.
CordenPharma announced in an Aug. 24, 2017 press release that a FDA warning letter received on May 20, 2016 by CordenPharma Latina, located near Sermoneta, has been closed, with a closeout date of Aug. 15, 2017. CGMP violations in the warning letter had included facility design, cleaning, and test procedure issues. The successful closure is the result of a holistic and systematic approach to remediate the observations throughout the facility, noted the company.
The company’s corporate compliance team developed a company-wide strategic approach to enhancing all quality and compliance systems by systematically reviewing and assessing each company facility and establishing harmonization programs, knowledge management, and sharing of best practices. To ensure effectiveness, the company 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.
CordenPharma’s leadership team is committed to enabling all facilities to operate according to the highest level of quality, compliance structures, and systems, with a consistent focus on patient safety, guidelines, legislations, and strict adherence to current industry standards. The company is achieving and sustaining these quality and compliance objectives proactively through continuous improvement strategies and collaboration with regulatory agencies.