FDA 483 - AAA Molybdenum Products Inc - December 05, 2024

AAA Molybdenum Products, Inc. in Broomfield, CO, an API manufacturer, was cited with six observations during an FDA inspection from December 3-5, 2024. The inspection revealed significant deficiencies in validation procedures, equipment qualification, cleaning and storage practices, recordkeeping, and document review processes for ATTM API manufacturing. These issues indicate a lack of adequate controls to ensure product quality and prevent contamination.