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

An FDA inspection of Shalini Iyengar, MBBS, a clinical investigator in Hexham, Northumberland, United Kingdom, revealed significant deficiencies in maintaining adequate and accurate case histories for a Phase 3 vaccine efficacy study. The firm failed to properly document the chain of custody for critical study samples, including destroying confirmation forms, not maintaining essential documentation, and having inconsistent signatures on processing and shipping logs. These issues indicate a serious lack of data integrity for the evaluation of vaccine efficacy.