FDA 483 - Richy Agajanian, M.D. - March 07, 2019

An FDA inspection conducted at Richy Agajanian, M.D., a clinical investigator firm in Whittier, CA, from February 26 to March 7, 2019, resulted in a Form FDA 483 report. The inspection identified a significant observation regarding the firm's conduct of a clinical investigation.

The primary finding was that the investigation was not carried out in accordance with the signed statement of investigator and the approved investigational plan. Specifically, the firm failed to adhere to critical protocol requirements concerning patient safety and data management. Adverse events, including certain occurrences, for subjects US-047-13 and US-047-33 were not reported to the study sponsor via electronic forms as mandated by the protocol. Furthermore, these events were not medically addressed by the site.

Additionally, the firm failed to properly manage subject diaries. Diaries for subjects US-047-008 and US-047-039 were neither reviewed for evidence of specific conditions nor maintained by the study site, directly contravening protocol requirements.

These observations indicate a departure from regulatory expectations for clinical trial conduct, emphasizing the need for robust adherence to study protocols, accurate adverse event reporting, and diligent record-keeping to ensure patient safety and data integrity. While the FDA 483 itself is an observation document, it prompts the firm to respond with a plan for corrective and preventive actions to address these deficiencies and ensure future compliance.