Blood Center ABC plans to manufacture and sell blood products. What must they do upon starting operations?

Upon starting operations, Blood Center ABC must register with the FDA within five days and provide a current list of all products manufactured. This requirement is part of the regulatory framework established by the Food, Drug, and Cosmetic Act, which mandates that facilities that engage in the manufacture of biological products, including blood products, must correctly register with the FDA. This registration process ensures that the FDA is aware of all manufacturing sites and the products they produce, allowing for appropriate oversight and compliance with regulatory standards.

This registration allows the FDA to maintain an updated inventory of products and facilitates inspections and compliance checks. It is essential for blood centers, as they deal with biological products that are critical for health care applications, ensuring both safety and efficacy for end users. By providing a current list of manufactured products, Blood Center ABC ensures that the FDA can effectively monitor product safety and quality.

Other options do not align with the specific regulatory requirements for blood centers. Filing a New Drug Application is not applicable here, as this process is reserved for new drug approvals rather than registration of manufacturing facilities. Approval from the EMA is also not necessary since the EMA pertains to European regulatory standards and is not relevant for operations based in the U.S. While conducting a market analysis can be beneficial for business strategy,