FDA 483 - Fenwal International, Inc. - August 22, 2017

Fenwal International, Inc. in Maricao, PR, a sterile drug manufacturer, was cited for significant quality control deficiencies during an FDA inspection. The firm lacked adequate production and process controls, failed to thoroughly investigate discrepancies, and did not submit Field Alert Reports in a timely manner. Additionally, the facility experienced persistent pest infestations in critical manufacturing areas, indicating a severe lack of environmental control.