FDA 483 - Tyche Industries Ltd. - August 16, 2024

Tyche Industries Ltd in Kakinada, India, was inspected by the FDA from August 12-16, 2024, for API manufacturing. The inspection revealed significant deficiencies across multiple areas, including quality unit responsibilities, complaint handling, analytical method validation, equipment cleaning, employee training, incoming material testing, and supplier quality agreements. These issues indicate a systemic failure to comply with CGMP regulations, particularly concerning data integrity, product quality, and process control.