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# ‘Objectionable Conditions’ in 2 Clinical Trials
- URL: https://www.fdaweb.com/objectionable-conditions-in-2-clinical-trials-2/
- Published: 2022-06-14T12:00:00.000Z
- Updated: 2026-09-14T17:48:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152054

An 8/4-8/20/21 FDA inspection at ACRC Studies, Poway, CA, conducted by Dr. **Smitha Reddy**, found “objectionable conditions” in the conduct of two clinical investigations. A 5/27 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/smitha-c-reddy-mdacrc-studies-llc-634702-05272022?ref=fdaweb.com) says the inspection was part of the agency’s Bioresearch Monitoring Program. The letter says a review of the FDA Establishment Inspection Report, documents submitted with the report, and Reddy’s 10/8/21 written response, indicate that she did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act and applicable regulations governing the conduct of clinical investigations.

The letter says Reddy failed to ensure that the investigation was conducted according to the investigational plan.

“While we acknowledge the actions your site has taken to prevent recurrence of the observations noted in this letter, including the hiring of a quality assurance specialist, development of new standard operating practices, and site staff training, we request that you specify the corrective actions that you, as a clinical investigator, have taken to prevent similar violations in the future,” FDA says. The letter says Reddy should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with regulations.