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Cytovance Completes Second FDA PAI of Oklahoma Facilities

Demonstrates capabilities and cGMP compliance in manufacturing commercial products

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Cytovance Biologics has received a notification letter and an Establishment Inspection Reports (EIRs) from the U.S. Food and Drug Administration (FDA) for its Oklahoma City, OK 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 1-9, 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.
 
The company said this second PAI milestone demonstrates its capabilities and cGMP compliance in manufacturing commercial products for clients. “I am very proud of the entire Cytovance team that accomplished this major success,” said Eddie Miranda, vice president of quality, Cytovance Biologics. “Cytovance will continue to pursue the highest quality standard in its services to clients.”
 
Yan Wang, chief executive officer, Cytovance Biologics, said, “Compliance to cGMP is at the core of Cytovance’s business. Our clients demand it, and we are one hundred percent committed to it.”

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