FDA EIR - Vitalant - August 12, 2016

An FDA inspection of Blood Systems, Inc., operating as United Blood Services (UBS-Casper) in Casper, Wyoming, took place on August 12, 2016. This Level I performance goal inspection was conducted under Compliance Program 7342.001, which outlines the inspection framework for licensed and unlicensed blood banks, brokers, reference laboratories, and contractors. UBS-Casper operates as a registered and licensed fixed donor center, collecting Whole Blood, RBCs, Platelets, and Plasma.

The inspection covered critical systems including Quality Assurance, Donor Eligibility, and Production and Processing. Key activities reviewed or observed included equipment calibration and qualification, donor screening and eligibility determination, and the collection and packing of various blood products for shipment. Notably, the previous inspection on September 26, 2014, also concluded with no adverse findings and no FDA 483 issued.

During the current inspection, the investigator observed various operations, including donor health screenings, phlebotomy procedures, and product packing. At the closeout meeting with company management, no objectionable conditions or issues were identified. Therefore, no FDA 483 form, which lists observed inspectional observations, was issued, and no specific corrective actions were required from Blood Systems, Inc. following this inspection, indicating full compliance with the regulatory framework.