FDA 483 - Shalini Iyengar, MBBS - May 24, 2024

During an FDA inspection from May 20-24, 2024, Shalini Iyengar, MBBS, a clinical investigator in Hexham, Northumberland, United Kingdom, was cited for failing to maintain adequate and accurate case histories. Specifically, the firm did not properly document the chain of custody for samples used in a vaccine efficacy study, including issues with destroyed forms, unmaintained staff documentation, and inconsistent log signatures.