FDA 483 - Sitec Labs Limited - June 07, 2024

Sitec Labs Limited in Navi Mumbai received a Form 483 for significant data integrity and documentation issues during bioanalytical studies. Observations included unjustified re-injection of acceptable study runs, inadequate logbook documentation for sample movement, and discrepancies between bioanalytical reports and source documents regarding acceptance criteria failures. These issues indicate a lack of robust quality control and data management practices.