FDA 483 - Sunfood Corporation - August 29, 2022

Sunfood Corporation, a dietary supplement contract manufacturer and food repacker in El Cajon, CA, received 13 observations during an FDA inspection. The firm was cited for significant deficiencies in quality control, including failing to establish adequate specifications for components and finished products, lacking scientifically valid test methods and written laboratory procedures, and not properly documenting or investigating deviations, out-of-specification results, or customer complaints. Additionally, the firm did not maintain complete master and batch manufacturing records or have identified quality control personnel.