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

Source: https://www.globalkeysolutions.net/records/483/sijo-j-parekattil-md/b2af881a-340e-4d39-a734-04694de28882

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

---

## Details

- Record Type: 483
- Company Name: Sijo J. Parekattil, M.D.
- Inspection Date: 2025-07-17
- Product Type: other
- Office Name: Florida District Office
- Summary: An FDA inspection of Sijo J. Parekattil, M.D. in Winter Garden, FL, a clinical investigator, revealed significant deficiencies in the conduct of Protocol CIP-002. Observations included failure to follow the investigational plan, such as enrolling a subject who did not meet inclusion criteria, prohibited advertising, and delayed reporting of a serious adverse event. Additionally, subject case history records were found to be inaccurate due to incorrect transcription of source data.

## Related Documents

- [483 - 2025-07-17](https://www.globalkeysolutions.net/records/483/sijo-j-parekattil-md/524387a3-69ca-424f-9610-55a85b9d807f)

## 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/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9