FDA 483 - Intarcia Therapeutics, Inc. - January 17, 2020

The FDA inspected Intarcia Therapeutics, Inc. in Hayward, CA, a drug manufacturer, and identified significant deficiencies. The inspection revealed repeated issues in aseptic processing, laboratory controls, and production controls, indicating a lack of adequate systems to ensure drug product quality and sterility. These observations highlight critical failures in process validation, environmental monitoring, and equipment maintenance, posing potential risks to product integrity.