FDA 483 - Astellas Pharma Inc. - June 06, 2025

The FDA conducted an inspection of Takahagi Technology Center, led by Nobuo Kasahara, from June 2nd to June 6th, 2025. This inspection resulted in the issuance of an FDA Form 483, detailing two significant observations related to the company's manufacturing practices.The first observation highlighted a deficiency in the Quality Unit's documented responsibilities. Specifically, the company lacked a written control strategy to ensure impurity levels, identified as related substances or intermediates with the potential to form drug substance, remained below acceptable limits. While a single test showed impurity levels below the acceptable intake level, the absence of a documented strategy was a concern.The second observation noted inadequate controls within computerized systems to prevent unauthorized data changes. For example, raw and processed data used for calculating particle size distributions of drug substance could be deleted without an audit trail to track these modifications. Data backups for this system were also mentioned, but the lack of audit trails for deletions was a key issue.These observations indicate potential deviations from Current Good Manufacturing Practices (CGMP) and necessitate a formal response from Takahagi Technology Center outlining their proposed corrective and preventive actions to address each deficiency and ensure future compliance.