FDA EIR - C S Bio Co. - February 17, 2022

The FDA conducted a preannounced surveillance Good Manufacturing Practice (GMP) inspection of CS Bio Company, a non-sterile Active Pharmaceutical Ingredient (API) manufacturer in Menlo Park, CA, from February 14 to 17, 2022. This inspection, part of the OPQO Division IV FY22 Work Plan and adhering to CPGM 7356.002F for API process inspections, reviewed the company's Quality, Materials, and Laboratory Controls systems. At the time of the inspection, CS Bio Company was not manufacturing drug substance for U.S. commercial products but maintained Exenatide for potential use in clinical research. While no Form FDA 483 (Inspectional Observations) was issued, the FDA investigator discussed several key areas with company management. These included a lack of adequate documentation and status labels for returned Exenatide drug substance stored without proper quality unit oversight, and insufficient documentation for all steps of cGMP laboratory investigations. Additionally, the inspection prompted a review of the company's establishment registration status given that it was not manufacturing commercial API for the U.S. Management acknowledged these items and committed to meeting regulatory expectations. Previous observations from a 2017 inspection were reviewed and found to have been adequately corrected.