FDA 483 - Peet John J MD - July 14, 2024

The FDA issued a Form 483 to Peet John J MD following an inspection conducted from June 24 to July 16, 2024. The inspection revealed significant deviations from regulatory requirements for clinical investigations, primarily concerning the conduct of a specific study protocol. Key observations highlighted that the investigation was not carried out according to the signed statement of the investigator and the investigational plan. Issues included delegating crucial follow-up visits, which involved physical exams, lab evaluations, and adverse event assessments, to personnel lacking the necessary qualifications. Furthermore, the protocol for the primary study endpoint was inconsistently followed, with inadequate documentation for data changes, impacting data integrity. There was also a failure to properly screen a subject, and adverse events lacked proper causality assessments. The investigational product was not stored according to required conditions, compromising its integrity. The inspection also identified deficiencies in investigational drug disposition records, noting instances of subject underdosing and discrepancies in drug shipments that made it impossible to confirm proper active drug or placebo administration. Finally, the firm failed to maintain accurate and complete case histories, with undocumented changes to critical study data and a lack of translation documentation for a Spanish-speaking subject's secondary endpoint assessments. These observations indicate non-compliance with the Federal Food, Drug, and Cosmetic Act, necessitating prompt corrective actions and a comprehensive response from Peet John J MD to address these serious findings.