Meitheal Pharmaceuticals Inc.: fosfomycin

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.

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.

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