FDA 483 - Choksi Laboratories Limited - June 01, 2016

An FDA inspection of Choksi Laboratories Ltd. in Indore, India, a control testing laboratory, revealed significant deficiencies in laboratory records and data integrity practices. The firm failed to maintain complete data, ensure data reporting, review electronic raw data and audit trails, and properly document changes. Additionally, the quality control unit lacked adequate written procedures, approval responsibilities, and scientifically sound laboratory controls for specifications and chemical shelf-life.