Cytovance Biologics has announced that the US 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.”