FDA 483 - Longhorn Vaccines And Diagnostics LLC - October 30, 2025

Longhorn Vaccines And Diagnostics LLC, a medical device manufacturer in Bethesda, MD, was inspected and found to have significant deficiencies in its quality system. The inspection revealed a widespread failure to establish and maintain required quality system procedures, including those for management review, audits, design controls, complaints, and CAPA. Additionally, the firm lacked a proper design history file for its PrimeStore® MTM device, failing to document design development and changes.