Juno Therapeutics Inc, a subsidiary of Bristol-Myers Squibb – FDA EIR, May 15, 2019

An FDA routine surveillance inspection of Juno Therapeutics Inc. in Seattle, WA, was conducted from May 9 to May 15, 2019. This was the first FDA inspection for the company, which was acquired by Celgene Corporation in 2018. The inspection, overseen by the Center for Biologics Evaluation and Research, focused on the company's compliance with Bioresearch Monitoring regulations for sponsors, contract research organizations, and monitors (Compliance Program 7348.810). The scope of the inspection included a review of standard operating procedures, contract agreements, sponsor oversight practices, the vendor selection process, test article management, and the selection and monitoring of clinical sites. Financial disclosure forms and Investigator Statements (FDA Form 1572) for all investigators were also examined. Significantly, the inspection concluded without the issuance of an FDA Form 483, "Inspectional Observations," indicating that no objectionable conditions or significant regulatory violations were identified. Furthermore, no items were discussed with management at the closeout meeting, and no samples were collected. This outcome signifies a positive finding for Juno Therapeutics Inc., with no immediate required regulatory actions stemming from this surveillance inspection.