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

Source: https://www.keypedia.com/records/483/shalini-iyengar-mbbs/a8b2521d-fbcf-4f32-8993-35168410e9fb

> 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: Division of Blood Components and Devices
- Summary: 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.

## Related Documents

- [483 - 2024-05-24](https://www.keypedia.com/records/483/shalini-iyengar-mbbs/03efafa7-fb75-4622-b644-0520cfca24f4)

## 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/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917