FDA 483 - American Red Cross - September 07, 2023

During an inspection conducted from September 5-7, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to the American Red Cross, located in Virginia Beach, VA. The inspection of this blood donor center identified a significant observation related to the handling of blood products.

Specifically, the FDA investigator observed a failure to properly store platelets immediately after collection and resuspension. These platelet units were documented and observed on September 5, 2023, to be resting on a countertop adjacent to the product collection floor. The critical issue was that these units were neither being assessed or monitored for temperature nor subjected to continuous gentle agitation, which is required for storage at 20-24 degrees Celsius, or stored at 1-6 degrees Celsius.

This observation indicates a deviation from established regulatory expectations for the proper storage of blood components, which is crucial for maintaining product quality and patient safety. The FDA 483 report, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, details these inspectional observations. The American Red Cross is expected to address this finding, either by discussing objections or submitting information regarding corrective actions implemented or planned, to ensure compliance with regulatory standards.