FDA EIR - Cambridge Biomedical Inc - April 20, 2018

An FDA inspection of Cambridge Biomedical Research Group Inc. in Boston, MA, was conducted from April 18-20, 2018. This was a BIMO program inspection performed by the Office of Study Integrity and Surveillance (OSIS), focused on a study data audit and verification, falling under the regulatory framework for Contract Research Organizations. A significant outcome of the inspection was that no FDA Form 483 was issued, indicating that no objectionable conditions requiring immediate regulatory action were identified. However, several observations were discussed with management. These included incomplete documentation for specific laboratory procedures like cell transfection, qPCR reagent setup, and traceability for method validation stability samples. Inspectors also noted an incomplete chain of custody for a plasmid, specifically regarding changes in storage conditions and expiration dates. Furthermore, original failed qPCR assay data was not consistently present in master electronic files, with only repeat data initially reported. Cambridge Biomedical's management acknowledged these observations, indicating that documentation practices have undergone significant improvements since the studies were initially conducted. They committed to enhancing future documentation for method validation samples and provided amended electronic records and explanatory notes-to-file for the identified qPCR discrepancies.