FDA 483 - Astellas Pharma Inc. - October 27, 2023

This FDA Form 483 document details an inspection observation regarding deficient complaint records. The facility's market complaint records lack scientifically sound justification for identified root causes. Specifically, two closed market complaints for KD) (4) 1mg and KD) (4) 1mg, both related to a "lack of effect," had unidentified root causes.

For market complaint #373593KD) (4) 1mg, associated with bulk batch ~(D) (4) J, four complaints were reported between November 24, 2022, and February 7, 2023. The investigation for this complaint did not include a batch review, analytical data review, or retain sample trending data review.

Similarly, for market complaint #316281'.{6 f {4n mg, linked to bulk batch fl{6 r {4)7, five complaints were reported between May 19, 2023, and July 28, 2023. This investigation also lacked a batch review, analytical data review, and retain sample trending data review.

The observation indicates a deficiency in the quality system's complaint handling procedures, specifically concerning thoroughness of investigations and root cause identification.