FDA 483 - FALCON SYSTEM OF AYURVEDIC PRODUCTS - November 13, 2024

FALCON SYSTEM OF AYURVEDIC PRODUCTS in Belgaum, India, was cited with 11 observations during an FDA inspection, revealing severe deficiencies in their quality control and manufacturing processes for botanical dietary supplements. The firm lacked essential written procedures, specifications, and controls for raw materials, finished products, and sanitation, leading to significant risks of contamination and adulteration. These issues indicate a fundamental failure to adhere to good manufacturing practices, raising serious concerns about the safety and quality of products exported to the U.S.A.