Polarean Inc.: Xenoview

1. The degree of polarization of xenon-129 hyperpolarized is a critical quality attribute of the drug component in your drug-device combination product.

Submit to the application the master batch record and executed batch records for production of xenon-129 hyperpolarized from hyperpolarizer © manufactured)

During a recent inspection of the Polarean Inc. (FEI:3010132318) manufacturing facility or this application, our field investigator conveyed deficiencies to the representative of he facility.

Satisfactory resolution of these deficiencies is required before this application may be approved.

During a recent inspection of the we manufacturing facility for this application, our field investigator conveyed deficiencies to he representative of the facility.