Oklahoma City, OK July 24, 2017. Cytovance hosted an unannounced FDA inspection Tuesday, July 11th 2017. The inspector conducted the inspection over an eight day period and focused on Quality Systems. Overall the inspection was very positive and the inspector acknowledged that the site had already identified and taken action on most of the 4 observations. Specifically, Cytovance had taken action to address the facility improvements. All the facility updates are scheduled to be completed during Cytovance’s end of summer shutdown.
“This was a great stepping stone for our quality systems and facility as we get close to our first PAI which we expect later in the year” stated Cytovance’s Vice President of Quality, Maria Lopez. “I am proud of my team and this inspection reiterates Cytovance’s commitment to become a first in class contract manufacturer of our client’s parenteral drug candidates. “
“Cytovance remains committed to providing the highest quality services and therapeutics to our clients,” said Darren Head, president and CEO of Cytovance Biologics, “I know we will work diligently together to complete these actions in a timely manner.”
About Cytovance Biologics
Cytovance® Biologics is a biopharmaceutical contract manufacturing company specializing in the production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. In addition to its cGMP manufacturing services, the company offers process development, cGMP cell banking and support services from its Oklahoma City state-of-the-art facilities.
Cheryl Tuck 405-319-8309