FDA 483 - Active Intelligence LLC - March 08, 2024

Active Intelligence LLC, an OTC drug manufacturer in Cherryville, NC, was cited for significant deficiencies in its quality control and facility management during an FDA inspection. The firm lacked essential written procedures for stability testing and annual product reviews, indicating a systemic failure in evaluating drug product quality. Additionally, observations highlighted poor control over labeling materials and inadequate handling and storage of components, leading to potential contamination and mix-ups.