FDA EIR - Gilead Sciences, Inc. - April 04, 2019

A routine Current Good Manufacturing Practices (cGMP) inspection of Gilead Sciences, Inc. in Foster City, CA, was conducted by the FDA from March 28 to April 4, 2019. The inspection focused on the Quality, Material, and Laboratory Systems for commercial drug products like Genvoya®, Harvoni®, and Viread®, and their associated Active Pharmaceutical Ingredients (APIs). These products fall under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, specifically Section 501(a)(2)(b), requiring adherence to cGMP. No formal FDA Form 483 was issued; however, five verbal discussion items were presented to management. These included observations regarding the firm's lack of identification for recovered microbes to assess product and patient risk, the absence of trend analysis for microbial results (including alert/action limits), and a procedural gap where corrective and preventative actions (CAPAs) were not explicitly required for critical deviations. Furthermore, an investigation omitted information on analyst retraining relevant to a deviation's root cause, and an initial Field Alert Report (FAR) failed to meet its designated submission deadline. Gilead Sciences committed to addressing the microbial identification and trending issues by Q4 2019 and agreed to update its deviation management procedure to mandate CAPAs for critical deviations. One issue with deviation management was corrected during the inspection.