FDA 483 - AML Riverside, LLC - April 03, 2019

AML Riverside, LLC, a drug manufacturer in Fort Dodge, IA, received a Form 483 citing significant deficiencies during an FDA inspection. The observations included a lack of strict control over drug product labeling, failures within the quality control unit regarding overdue CAPA items and product trending, and non-adherence to established laboratory control mechanisms for investigative testing. These issues indicate a need for improved adherence to Good Manufacturing Practices.