FDA 483 - Teyro Labs Private Limited - November 12, 2025

Teyro Labs Private Limited in Kanchivakkam, India, was inspected by the FDA from November 3-12, 2025, revealing significant deficiencies in sterile drug manufacturing. The inspection found issues with equipment qualification, personnel gowning, equipment cleaning and maintenance, process validation, and investigation of discrepancies, indicating a lack of adequate controls to ensure drug product quality and sterility. These observations highlight serious concerns regarding the firm's adherence to cGMP regulations.