Seattle Genetics Hit With 483 for Documentation and Adverse Event Reporting Failures

September 25, 2015

Seattle Genetics received a six-observation Form 483 from the FDA for documentation and adverse event reporting failures related to its only approved product — cancer drug Adcetris.

During a May 27 to June 9 inspection, investigators documented 30 adverse drug event reports the company received between April 1, 2013, and May 18 of this year that were submitted to the FDA after the 15 calendar-day deadline, the form says.

There were also no written records of an out-of-specification investigation into a stability sample of Adcetris. The OOS involved a retest in which two assays of the product were recorded as “invalid,” but the investigation was closed without documented rationale for the invalidated test results.

Seattle Genetics also failed to retain electronic versions of the executed batch records of Adcetris bulk drug substance and finished drug product, leaving no means to verify that the printed version of the electronic records is an accurate representation of what was provided to Seattle Genetics by its contract manufacturers, the form says.

Seattle Genetics said that the 483 observations are minor and shouldn’t impact Adcetris or its production.

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