FDA 483 - David M Francyk - October 20, 2017

An FDA inspection of David M Francyk, a clinical investigator, was conducted from October 10-20, 2017, resulting in a Form FDA 483 report citing significant deviations from regulatory requirements and approved protocols. The primary issues identified include the failure to conduct the investigation in accordance with the signed statement of investigator and investigational plan. Specifically, one subject was improperly enrolled despite meeting exclusion criteria related to prior medication use. Additionally, the Clinical Research Coordinator consistently failed to follow study-specific procedures for vital sign measurements, ECGs, and sample collection, such as incorrect timing relative to subject positioning and other procedures. The inspection also noted a failure to maintain adequate and accurate case histories, with important concomitant medications (e.g., antibiotics, anesthesia) not being recorded in source documents and electronic case report forms. Furthermore, the facility failed to obtain informed consent in accordance with 21 CFR Part 50. In one instance, screening procedures, including urine collection and ECGs, were performed on a subject *before* their informed consent form was signed. These observations indicate a need for David M Francyk to implement robust corrective actions to ensure compliance with the Federal Food, Drug and Cosmetic Act and associated regulations, particularly regarding subject eligibility, protocol adherence, data integrity, and ethical conduct of clinical trials. The firm is expected to respond to these findings with a plan for correction.