Cytovance® Biologics Successfully Completes FDA Inspection

OKLAHOMA CITY, May 09, 2018 (GLOBE NEWSWIRE) — Cytovance® Biologics, Inc., a leading full-service biopharmaceutical contract development and manufacturing services company is pleased to announce the United States Food & Drug Administration (FDA) has concluded a successful Pre-License Inspection at Cytovance with no 483 observations. 

The focus of the five-day PLI was quality systems, facilities, maintenance programs and the manufacturing of client’s candidate product.

“We are very pleased with the result of the FDA inspection demonstrating Cytovance’s unwavering commitment to quality and patient safety,” stated Eddie Miranda, Vice President of Quality at Cytovance Biologics. “I am proud of the entire Cytovance team who achieved such a success. This major milestone paved the way for Cytovance Biologics to enter commercial manufacturing of biopharmaceuticals beyond clinical production.  Cytovance remains committed to providing the highest quality and long-term services to its clients.”



Media Contact:
Cheryl Tuck
ctuck@cytovance.com   

 

Nice Insight

Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.

Q: