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

Source: https://www.keypedia.com/records/483/shalini-iyengar-mbbs/03efafa7-fb75-4622-b644-0520cfca24f4

> FDA 483 for Shalini Iyengar, MBBS on May 24, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shalini Iyengar, MBBS
- Inspection Date: 2024-05-24
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.keypedia.com/companies/shalini-iyengar-mbbs/5cd7d046-4c62-4a7b-92ef-260d9973c1a2

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321