FDA 483 - Hikma Pharmaceuticals USA Inc. - September 10, 2019

Hikma Pharmaceuticals USA Inc. in Cherry Hill, NJ, a manufacturer of combination drug/device products, was cited for significant deficiencies during an FDA inspection. Observations included inadequate stability data for a drug product, failure to thoroughly investigate batch failures, and issues with maintaining device history records and establishing design review procedures for combination products. These findings indicate a lack of robust quality system controls for both drug and device aspects of their operations.