Cytovance® Biologics announced it has received a notification letter and an Establishment Inspection Reports (EIRs) from the U.S. Food and Drug Administration (FDA) for its Oklahoma City site, FEI registration numbers: 3006341547. The notification and the EIR are to close, under 21 CFR 20.64(d)(3), a Pre-Approval Inspection (PAI) that occurred between May 1st and May 9th, 2019, for a client’s product. The client has filed its product with the FDA for market approval.
This was Cytovance’s second PAI. The previous PAI, associated with a recent FDA market approval, took place in April 2018.
This second PAI is a major milestone for Cytovance, further demonstrating its capabilities and cGMP compliance in manufacturing commercial products for clients. Eddie Miranda, Vice President of Quality at Cytovance Biologics, states, “I am very proud of the entire Cytovance team that accomplished this major success. Cytovance will continue to pursue the highest quality standard in its services to clients.”
“Compliance to cGMP is at the core of Cytovance’s business,” said Yan Wang, CEO of Cytovance Biologics, “Our clients demand it, and we are one hundred percent committed to it.”