FDA 483 - Peet John J MD - July 16, 2024

An FDA inspection conducted at Peet John J MD in The Woodlands, TX, from June 24 to July 16, 2024, resulted in the issuance of a Form FDA 483. This document outlines significant observations regarding the conduct of a clinical investigation, indicating non-compliance with regulatory standards. Key issues identified include the failure to conduct the investigation in accordance with the signed statement of investigator and investigational plan. Specifically, follow-up visits, including physical examinations and adverse event evaluations, were delegated to unqualified personnel. The primary study endpoint data collection was inconsistent, lacking proper documentation for changes and raising concerns about data integrity, especially given multiple Clinical Research Coordinator changes. Protocol deviations also involved a subject who lacked a required screening assessment and an absence of adverse event relatedness evaluations. Additionally, investigational product was not stored at the required temperature for a period. Further observations detailed inadequate investigational drug disposition records, with subjects receiving incorrect dosing amounts, and issues with the accountability of blinded study drug vials, making it impossible to determine if active drug or placebo was administered. The inspection also highlighted failures in maintaining adequate and accurate case histories, including undocumented alterations to critical endpoint data after original entry and a lack of translation documentation for a secondary endpoint for a Spanish-speaking subject who consented in Spanish. These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, require the clinical investigator, Dr. John J. Peet, to promptly address these deficiencies and implement comprehensive corrective actions to ensure the integrity, safety, and regulatory compliance of future clinical studies.