FDA 483 - Central California Blood Center - August 29, 2025

From August 25 to August 29, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the Central California Blood Center in Fresno, California. The inspection revealed several operational deficiencies regarding blood collection and processing. Key violations included improper donor arm preparation, where staff used non-sterile solutions and failed to follow manufacturer instructions for drying and scrubbing, potentially compromising the sterility of the blood containers. Additionally, the facility failed to investigate technical errors and warning messages generated during laboratory testing for blood assays. The FDA also noted significant gaps in the center"s written protocols. Specifically, the organization lacked standard operating procedures for following up with donors who experienced negative reactions during blood collection and failed to provide detailed, step-by-step instructions for Hepatitis C virus screening, instead relying on external equipment manuals. These observations were issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While this report does not represent a final agency determination, the Central California Blood Center is expected to address these findings. The firm must discuss any objections or planned corrective actions with the FDA representative or submit a formal written response to the FDA district office to ensure future compliance and public safety.