FDA 483 - Emergent Manufacturing Operations Baltimore LLC. - April 20, 2020

EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC, a contract testing laboratory in Baltimore, MD, was cited for significant deficiencies during an FDA inspection. The observations primarily concern severe data integrity issues, including unprotected electronic data, unreviewed audit trails, and manual manipulation of records. Additionally, the firm failed to follow established laboratory procedures, ensure adequate quality control unit oversight, provide proper employee training, and correctly manage rejected materials.