FDA 483 - Balassa Laboratories, Inc. - April 07, 2023

An FDA inspection of Balassa Laboratories, Inc. in Port Orange, FL, an OTC drug manufacturer, revealed three significant observations related to current Good Manufacturing Practices. Issues included inadequate handling and storage of components leading to potential cross-contamination, missing execution results for equipment installation and operational qualifications, and a failure to properly identify the status of major manufacturing equipment.