FDA 483 - AIE Pharmacueticals, Inc. - September 17, 2021

AIE Pharmacueticals, Inc. in Ontario, CA, a dietary supplement manufacturer, received eight observations during an FDA inspection. The firm was cited for significant deficiencies across its manufacturing processes, including a lack of established specifications for components and finished products, inadequate contamination prevention, and incomplete master and batch production records. These issues highlight a systemic failure in quality control operations, indicating a high severity of non-compliance with good manufacturing practices.