FDA 483 - Aura Cacia - December 01, 2023

Aura Cacia, an OTC drug manufacturer in Urbana, IA, was cited with five observations during an FDA inspection from November 27 to December 1, 2023. The firm exhibited significant deficiencies in its quality control systems, including inadequate component testing, lack of written production and process control procedures, and insufficient stability data to support product expiration dates. These issues indicate a systemic failure to ensure the identity, strength, purity, and quality of its OTC hand sanitizer products.