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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 PA...

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