Conjupro Biotherapeutics Inc.: irinotecan liposome

Your complete response should include the date(s) of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.

, listed in this application, FDA conveyed deficiencies to the representative of the facility.

The FDA conducted an expedited, risk-based review of the available information from the inspection and determined that the deficiencies represent significant issues that adversely impact the facility's ability to perform the designated functions described in your application.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response resubmission.

FDA Form 483. If the FDA determines the deficiencies resolved following a full review of the inspection and 483 responses after this Complete Response Letter, the facility will be informed.

Otherwise, further assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.