St. Jude Children's Research Hospital – FDA EIR, May 16, 2019

An FDA inspection was conducted at St. Jude Children's Research Hospital in Memphis, TN, from May 13-16, 2019. This comprehensive review focused on an In Vivo Bioavailability/Bioequivalence study, governed by Compliance Program 7348.003, in support of a drug application. While no FDA Form 483 was issued, indicating no official violations, several discussion items were raised with management during the closeout meeting. These included ensuring investigational drug product is not destroyed before monitor review and verifying drug dispensation consistently follows protocol, particularly regarding specific dispensing methods. The inspection also highlighted the need for standardizing documentation for pharmacokinetic blood sample collections, which currently vary between electronic and paper records. Furthermore, a general reminder was provided on Good Documentation Practices, emphasizing proper correction methods, comprehensive note-taking, and clear referencing for inclusion/exclusion criteria. Management acknowledged these points, with commitments to clarify protocols, develop a new Standard Operating Procedure for sample collection, and retrain personnel. The inspection concluded with a reminder of responsibilities under 21 CFR regulations, aiming to reinforce compliance and improve operational consistency.