CordenPharma International would like to notify customers about a warning letter received from the USFDA 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. 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.
Over the course of the next 10 days, CordenPharma International Account Directors and Platform Managers will be touching base with their customers directly to discuss the scope and effects of the warning letter, highlight the remediation steps already taken since the inspection and relay CordenPharma’s ongoing strategy for effective response.
If you would like to be contacted regarding the warning letter > please click here.
Dr. Michael Quirmbach
Vice President, Marketing & Sales, CordenPharma International
Read the full press release here