FDA 483 - Vitalant - March 18, 2022

During an FDA inspection conducted from February 9 to February 18, 2022, Vitalant, a blood bank located in Brisbane, CA, received a Form FDA 483 detailing an observation of objectionable conditions. This document, issued under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, highlights a critical issue concerning the firm's adherence to manufacturer instructions for blood product handling.The primary observation noted Vitalant's failure to use supplies and reagents consistent with manufacturer guidelines. Specifically, the company was found not to be following the operator

’s manual for its Component Collection System when processing Apheresis Red Blood Cells (ARC). Since September 1, 2021, numerous ARC units were collected using this system and subsequently irradiated. Despite the manufacturer's manual stipulating that such irradiated red cells should expire a certain number of days from the date of collection if irradiated using a specific type of irradiator (which Vitalant utilized and confirmed exceeded a certain radiation dose limit), Vitalant erroneously assigned an expiration date based on the date of irradiation. This practice led to potentially extending the shelf-life beyond the manufacturer's validated period, impacting product quality and patient safety.This FDA 483 serves as an official communication of these observed deviations and requires Vitalant to provide a detailed response outlining immediate and long-term corrective actions to address the non-compliance and ensure all blood products are processed and dated according to established, validated procedures.