# FDA 483 - Sijo J. Parekattil, M.D. - July 17, 2025

Source: https://www.globalkeysolutions.net/records/483/sijo-j-parekattil-md/524387a3-69ca-424f-9610-55a85b9d807f

> FDA 483 for Sijo J. Parekattil, M.D. on July 17, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sijo J. Parekattil, M.D.
- Inspection Date: 2025-07-17
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Sijo J. Parekattil, M.D., a clinical investigator, revealed significant deviations from an investigational plan and protocol for Protocol CIP-002. Observations included issues with subject eligibility, prohibited advertising, delayed serious adverse event reporting, and inaccurate subject case history records. These findings indicate a lack of adherence to clinical trial regulations and good clinical practice.

## Related Documents

- [483 - 2025-07-17](https://www.globalkeysolutions.net/records/483/sijo-j-parekattil-md/b2af881a-340e-4d39-a734-04694de28882)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/emily-c-caldwell/101868aa-0586-4d37-8bc6-194f43d66cb7)

Company: https://www.globalkeysolutions.net/companies/sijo-j-parekattil-md/8e0d299d-51e8-4007-b39f-75db849f675a

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6