FDA EIR - Carlos M. Martinez, M.D. - June 22, 2024

An FDA inspection of Clinical Investigator Carlos M. Martinez, M.D., located in Cutler Bay, FL, was conducted from July 10 to July 22, 2024. This high-priority compliance inspection, performed under the Bioresearch Monitoring Clinical Investigators regulatory framework (Compliance Program 7348.811), reviewed two clinical drug protocols. The inspection revealed significant deviations from regulatory requirements and investigational plans, resulting in the issuance of a Form FDA 483 with two main observations.

First, Dr. Martinez failed to conduct an investigation according to the signed statement of investigator and investigational plan (21 CFR 312.60). Specifically, for one protocol, 25 subjects were enrolled without required medical documentation and underwent unapproved inpatient admissions with additional, unscheduled study visits not outlined in the protocol or informed consent. Second, there was a failure to prepare or maintain adequate and accurate case histories (21 CFR 312.62(b)). For another protocol, 28 subject records were missing critical components of a key assessment.

Additional discussion items included a failure to dispense investigational product accessories correctly, delayed reporting of temperature excursions for investigational product storage, and improper redaction of subject medical records, hindering verification. Dr. Martinez acknowledged the observations and committed to submitting a written response to the FDA within 15 business days. The Agency noted that further review could lead to administrative actions, injunctions, civil money penalties, or prosecution.