FDA 483 - Daiichi Sankyo Europe GmbH - July 18, 2025
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This FDA Form 483 was issued to Daiichi Sankyo Europe GmbH, a drug product manufacturer in Pfaffenhofen A.D. Ilm, Germany, following an inspection from July 14-18, 2025. The inspection revealed significant deficiencies in laboratory record-keeping, inadequate investigations into deviations and out-of-specification results, and failures in equipment cleaning and maintenance procedures. These observations indicate a lack of robust quality control and data integrity practices.
ID · 5f48dc36-8c0c-4493-a634-ec2288eadad6