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

An FDA surveillance inspection of CS Bio Company, a non-sterile Active Pharmaceutical Ingredients (API) manufacturer, was conducted from February 14-17, 2022. This visit, part of the OPQO Division IV FY22 Work Plan, adhered to current Good Manufacturing Practice (GMP) guidelines for API process inspections. At the time, CS Bio was not manufacturing Exenatide drug substance for U.S. commercial products, but held existing inventory for potential clinical research.

While no formal FDA 483 observations were issued, the inspection revealed and discussed three key areas with management. These included insufficient documentation and labeling for returned drug substance stored without proper quality unit oversight; inadequate documentation of all steps in laboratory investigations, particularly supporting data for invalidating out-of-specification results; and the company's establishment registration status given their current lack of commercial API production. Management acknowledged these concerns and committed to improving future practices. Furthermore, a review confirmed that all three observations from a previous 2017 inspection concerning critical material storage, equipment qualification, and quality document review had been adequately addressed by the company.