# FDA 483 - Ascendant Research Clinic, LLC - October 23, 2025

Source: https://www.keypedia.com/records/483/ascendant-research-clinic-llc/8f53f54b-dc1c-47cd-8ca1-a91dacbc3eef

> FDA 483 for Ascendant Research Clinic, LLC on October 23, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascendant Research Clinic, LLC
- Inspection Date: 2025-10-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East III
- Summary: An FDA inspection was conducted at Amid Hamidi, M.D. / Ascendant Research Clinic, LLC in Marion, SC, from October 20-23, 2025. The inspection resulted in the issuance of a Form FDA 483, detailing observations of objectionable conditions. The main violation identified was the failure to conduct a clinical investigation in accordance with the signed statement of investigator and the approved investigational plan. Specifically, the firm did not ensure that required blood samples were collected from subjects according to the study protocol's specified timeframes.

Key issues included the untimely collection of blood samples for multiple subjects during Visit 2 (Day 2), where samples were not collected within the required window following investigational product administration. Additionally, several subjects' blood samples for Visit 5 (Day 14) were not collected as stipulated by the protocol. These deviations from the established study plan compromise the integrity of the clinical data.

This FDA 483 document, issued pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, serves as a formal notification of these observations. While not a final determination of compliance, it requires Amid Hamidi, M.D. to promptly review and address these findings by implementing corrective actions to ensure adherence to regulatory frameworks and to prevent the recurrence of such protocol deviations in future clinical trials.

## Related Officers

- [investigator](https://www.keypedia.com/people/anthony-j-grace/023993d4-63ef-40ba-a538-42479b65011c)

Company: https://www.keypedia.com/companies/ascendant-research-clinic-llc/db499b6a-2062-4994-8473-748100221446

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iii/fe10072a-a5ee-4949-9781-1942c4334ab7