# FDA 483 - Chrisette M. Dharmagunaratne, M.D. - February 07, 2025

Source: https://www.globalkeysolutions.net/records/483/chrisette-m-dharmagunaratne-md/17b15dba-e97e-4c1c-bb0d-e9fa29899767

> FDA 483 for Chrisette M. Dharmagunaratne, M.D. on February 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chrisette M. Dharmagunaratne, M.D.
- Inspection Date: 2025-02-07
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Chrisette M. Dharmagunavatne, M.D., a clinical investigator in Dallas, TX, revealed a significant deviation from the investigational plan. The primary issue involved the incorrect dosing of three subjects due to a calculation error where pounds were used instead of kilograms for weight-based drug administration. This indicates a failure to adhere to the study protocol, potentially impacting subject safety and data integrity.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/travis-m-beard/a89f6d0b-dc5b-4adc-84f5-36e04b00fc2d)

Company: https://www.globalkeysolutions.net/companies/chrisette-m-dharmagunaratne-md/28cf8d8f-d23d-43d4-a8fd-a0a1ad3db109

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9