FDA 483 - Partner Therapeutics, Inc. - September 16, 2022

An FDA inspection of PARTNER THERAPEUTICS INC in Lexington, MA, revealed significant deficiencies in their adverse event reporting processes. The firm failed to report serious and unexpected adverse experiences from a postmarketing clinical study within the required timeframe, including cases where the investigator assessed a reasonable possibility of relatedness. Additionally, there was a lack of documentation for unsuccessful attempts to seek additional information regarding serious and unexpected adverse experiences, contrary to their own standard operating procedures.