FDA 483 - Eminent Services Corporation - April 28, 2025

An FDA inspection of EMINENT Services Corporation, a drug product repacker and relabeller in Frederick, MD, revealed significant deficiencies. Observations included inadequate computer system controls leading to potential data integrity issues, lack of routine calibration for critical temperature monitoring equipment, and failures in following quality control unit procedures for material handling. Additionally, the firm lacked written procedures for handling investigations and CAPA effectiveness checks.