FDA 483 - Vitalant - January 10, 2025

An FDA inspection of an unnamed facility was conducted from January 7-10, 2025, revealing a critical observation related to the collection of blood and blood components. The primary issue identified was the inadequacy of the firm's written standard operating procedures (SOPs), specifically regarding the "Alarm Checks and Error Messages - Automated/Apheresis Collections" (version 3.0). The SOP was deemed insufficient as it did not adequately address certain alarms, and crucially, staff were not consistently required to document non-recoverable alarms, contrary to established manual recommendations. These observations, documented under an FDA Form 483, are issued pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act. While the document itself serves as a report of observed conditions rather than a list of explicit mandates, the company is expected to promptly evaluate these findings and implement comprehensive corrective actions to rectify the procedural deficiencies and ensure full compliance with regulatory requirements for blood product collection.