FDA EIR - Worldwide Clinical Trials Early Phase Services, LLC - October 17, 2018

An FDA inspection of Worldwide Clinical Trials in San Antonio, TX, was conducted from September 27 to October 17, 2018. The inspection, carried out under Compliance Program 7348.003 for In Vivo Bioequivalence Studies, aimed to assess the facility's adherence to regulations, study protocols, human subject protection, and data validity for bioequivalence studies. The primary finding, documented in an FDA-483, highlighted a significant deviation from an investigational plan. Specifically, for a study protocol, a subject was inappropriately enrolled and dosed despite meeting an exclusion criterion (presence of Trichomonas Vaginalis at screening). The principal investigator had signed off on the lab report indicating this condition but failed to prevent the subject's dosing. This oversight was only identified later by Quality Control staff, indicating a failure to conduct the investigation in accordance with the protocol, as required by 21 CFR 312.60. Management acknowledged the protocol violation, confirming the subject should not have been enrolled. Worldwide Clinical Trials indicated they would formally respond to the FDA-483 observation. Additionally, the firm made a voluntary correction to its standard operating procedure for emergency cart inventory management during the inspection.