FDA 483 - ZECO, LLC - July 19, 2024

Zeco LLC, an OTC drug manufacturer in Chattanooga, TN, was cited for significant deficiencies across its quality control, materials, laboratory, and facilities systems. The inspection revealed a pervasive lack of written procedures, inadequate testing, and insufficient validation and control over manufacturing processes and components, indicating a fundamental failure to adhere to current Good Manufacturing Practices.