Eisai Handed Form 483 Citing Control Records, CAPA Procedures
The FDA has served drug manufacturer Eisai with a Form 483 after an investigation revealed laboratory control issues and incomplete records.
Five observations were cited in the Form 483, including that the firm failed to initiate CAPA procedures and follow established test procedures as well as laboratory control mechanisms. The company also neglected to address the reoccurrence of test failures.
Others deviations from the established test methods were observed. Specifically, the analyst missed a required step during testing of a drug product.