FDA 483 - Ioannis Lougaris VA Medical Center Laboratory Service (113) Blood Bank - August 26, 2022

An FDA inspection was conducted at the Ioannis Lougaris VA Medical Center, specifically its Hospital Transfusion Service in Reno, Nevada. The inspection took place over two days, from August 25 to August 26, 2022, and the amended inspectional observations report, Form FDA 483, was issued on October 24, 2022, to Grant M. Hayashi, M.D., the Medical Director. The inspection was performed under the authority of the Federal Food, Drug, and Cosmetic Act, particularly Section 704(b), which allows the FDA to report conditions or practices indicating potential non-compliance. Notably, this specific FDA Form 483, labeled as Amendment 1, reports a unique outcome. While an initial observation regarding equipment alarm settings was made, it was subsequently removed after further discussion with the facility's management, as it was deemed not to apply. Therefore, this final version of the FDA 483 document concludes with no actionable inspectional observations of objectionable conditions or practices requiring a formal response or immediate corrective actions from the Ioannis Lougaris VA Medical Center. This indicates that, following the comprehensive review process, the facility was not cited for any regulatory deficiencies in this specific report. This document confirms the inspection's findings and the resolution of the initial point of concern.