07.24.17
Cytovance Biologics has completed an FDA inspection that took place July 11, 2017 at its Oklahoma City facilities. The eight-day inspection focused on Quality Systems. Overall the inspection was positive and the inspector acknowledged that the site had already identified and taken action on most of the four 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” said 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 chief executive officer of Cytovance Biologics, “I know we will work diligently together to complete these actions in a timely ma Cytovance Biologics Inc.
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” said 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 chief executive officer of Cytovance Biologics, “I know we will work diligently together to complete these actions in a timely ma Cytovance Biologics Inc.
