FDA 483 - Partner Therapeutics, Inc. - September 16, 2022
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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.
ID · d0f4053c-58c5-4e76-8dea-035109e87090