FDA EIR - The Children's Hospital Corporation - August 02, 2019

The FDA conducted an inspection of Children's Hospital Corporation, operating as Boston Children's Hospital (BCH), a blood bank that collects, manufactures, and irradiates blood products. The inspection took place from July 29, 2019, to August 2, 2019. This review was part of the Biological Products Operations (OBPO) Division 1 Work Plan and guided by CPGM 7342.001 for blood bank inspections, along with PAC 42R878 concerning Zika Virus activities. The inspection covered critical systems including Quality Assurance, Donor Eligibility, Product Collection, Component Preparation, Product Testing, Labeling, and Quarantine/Storage Disposition. Notably, BCH had successfully addressed deficiencies identified during a previous inspection from January 30 to February 14, 2017. During the 2019 inspection, FDA investigators reviewed numerous records related to blood product collection, processing, irradiation, labeling, storage, equipment validation, quality control, emergency releases, biological product deviation reports, and donor/transfusion reactions. The firm's procedures for ZIKV testing by an external laboratory were also confirmed. Crucially, the inspection concluded with no significant deficiencies found, and consequently, no FDA Form 483 (Inspectional Observations) was issued to the hospital. Therefore, no immediate regulatory actions or corrective measures were required from Boston Children's Hospital as a result of this inspection.