FDA 483 - AIE Pharmacueticals, Inc. - September 17, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · c3f7ab59-f8ee-4524-8460-b865e74c94ac