FDA 483 - Sitec Labs Limited - March 29, 2024

Sitec Labs Limited, a biopharmaceutics clinical facility in Navi Mumbai, India, was cited for failing to maintain adequate and accurate records of clinical trial related activities according to good clinical practices. The inspection revealed significant issues with demonstrating the chain of custody for investigational products and PK samples. This included storing samples in an unvalidated and unmonitored freezer without proper documentation.