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

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from October 23-27, 2023, Astellas Pharma Inc., a drug manufacturer located in Yaizu, Shizuoka, Japan, received an FDA Form 483 for observed deficiencies. The primary observation noted was that the company's complaint records were inadequate. Specifically, market complaints concerning a "lack of effect" for certain drug products lacked scientifically sound justification for their root causes. Investigations into these complaints were found to be deficient, as they did not include essential elements such as comprehensive batch reviews, analytical data reviews, or analyses of retain sample trending data. Examples highlighted multiple instances where investigations concluded "no root cause" without sufficient supporting data or a thorough examination of complaint history for specific bulk batches. The FDA 483 document serves as a notification of these inspectional observations, requiring Astellas Pharma Inc. to respond with appropriate corrective and preventive actions to address the identified compliance issues related to their complaint handling system.