# FDA 483 - Taddese T. Desta, M.D. - November 22, 2019

Source: https://www.keypedia.com/records/483/taddese-t-desta-md/c63080c7-d853-43df-b137-d0113ffd8b37

> FDA 483 for Taddese T. Desta, M.D. on November 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Taddese T. Desta, M.D.
- Inspection Date: 2019-11-22
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: During an inspection conducted from November 18-22, 2019, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Dr. Taddese T. Desta, M.D., operating as a Clinical Investigator in San Diego, CA. The primary observation noted was a failure to prepare or maintain adequate and accurate case histories, specifically concerning observations and data relevant to a Phase III study (CNS7056-006) evaluating Remimazolam for colonoscopy patients.The inspection revealed multiple discrepancies between source documents and case report forms for study subjects. These included inconsistencies in MOAA/S and VAS scores at various time points, the absence of documentation for a concomitant medication (PEG 3350) in one subject's case report form, and differing time point assessments. Additionally, study drug batch numbers listed on patient dose preparation worksheets did not match the information recorded in the accountability log. These findings indicate a lack of robust data integrity in clinical trial record-keeping, which is a critical aspect of regulatory compliance for clinical investigators.The FDA 483 document serves as a notice of objectionable conditions observed during the inspection. Dr. Desta is expected to respond to the FDA, detailing the corrective actions taken or planned to address these observations and ensure future compliance with regulatory requirements for clinical trials.

## Related Documents

- [483 - 2019-11-22](https://www.keypedia.com/records/483/taddese-t-desta-md/ffe654ce-d7c2-4cae-ad06-c265af295808)

## Related Officers

- [Julian C. Hanson](https://www.keypedia.com/people/julian-c-hanson/489e27d9-0de6-4bf0-8aec-e5d500841f52)

Company: https://www.keypedia.com/companies/taddese-t-desta-md/deb7233e-45d4-4157-a301-46c9868bb53d

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b