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# ‘Objectionable Conditions’ in Clinical Investigation
- URL: https://www.fdaweb.com/objectionable-conditions-in-clinical-investigation/
- Published: 2023-08-23T12:00:00.000Z
- Updated: 2026-09-14T18:52:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155160

FDA says its 9/1-9/29/22 inspection at a clinical trial site maintained by **Angela Stupi** in Cranberry Twp., PA, found objectionable conditions for two trials of investigational drugs. The inspection was part of the agency’s Bioresearch Monitoring Program and found that Stupi did not comply with laws and regulations governing the conduct of clinical investigations and the protection of human subjects. An 8/8 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/angela-m-stupi-md-665471-08082023?ref=fdaweb.com) says Stupi failed to ensure that the investigation was conducted according to the investigational plan, and cited several issues.

The letter acknowledges the actions Stupi said she plans to take to address the violations, but says the response is inadequate because she did not include sufficient details about the corrective action plan, such as details on the policies and procedures being implemented.

“We emphasize that as the clinical investigator, it was ultimately your responsibility to ensure that this study was conducted properly and in compliance with FDA regulations, both to protect the rights, safety, and welfare of study subjects and to ensure the integrity of study data,” the agency says. “Your failure to ensure that subjects met eligibility criteria before enrollment in the study, and your failure to perform study procedures (including the administration of the study drug) as required by the protocol, raise significant concerns about the safety of subjects enrolled in this study and the reliability of data at your site.”

Stupi was told to respond with a list of specific actions being taken to prevent similar violations in the future.