SpringWorks Therapeutics, Inc. – FDA EIR, Mar 31, 2023

An FDA surveillance inspection of SpringWorks Therapeutics, Inc. was conducted at their Durham, NC facility from March 20 to March 31, 2023. This inspection, the firm's first, assessed compliance with applicable regulations, specifically referencing the Food, Drug, and Cosmetic Act (FD&C Act) and Compliance Program 7348.810. The inspection resulted in the issuance of a Form FDA 483, indicating one significant observation: a failure to ensure the clinical study was conducted in accordance with its investigational plan. This stemmed from a programming error that incorrectly included new tumors in primary endpoint calculations for seven subjects, contrary to the Statistical Analysis Plan, violating 21 CFR 312.50. SpringWorks management acknowledged this and initiated a corrective and preventative action (CAPA) plan, committing to revalidate data and submit corrected analyses. Additionally, the FDA investigator presented five discussion items highlighting further concerns. These included inconsistencies in Investigator Brochure updates affecting safety event evaluations, a notable lack of written procedures for critical activities like data management and vendor oversight, and insufficient documentation and evaluation of potential financial conflicts of interest for clinical investigators. Other issues involved a lack of specific detail in CAPA documentation and inadequate record retention, notably missing Data Monitoring Committee meeting minutes. SpringWorks management acknowledged these points, indicating plans to address them in their response to the FDA 483.