FDA 483 - Nakoda Chemicals Ltd. - January 18, 2016

An FDA inspection of Nakoda Chemicals LTD. in Hyderabad, India, from January 18-22, 2016, revealed a significant quality control issue. The firm failed to verify test methods and procedures used for the release of finished products, specifically the (b)(4) USP finished product. This indicates a lack of proper validation for critical manufacturing processes.