FDA 483 - AML Riverside, LLC - August 14, 2023

AML Riverside, LLC, a drug manufacturer in Fort Dodge, IA, was cited for significant quality control deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate product discrepancies such as empty finished product samples, inadequate labeling of processing equipment, and a lack of established procedures for preventing objectionable microorganisms. These issues indicate a need for improved adherence to good manufacturing practices.