Access Biologicals Llc – FDA EIR, Dec 14, 2016

An FDA comprehensive inspection of Access Biologicals LLC, a manufacturer of intermediary human bulk plasma for non-injectable and in vitro diagnostic products, was conducted in Vista, CA, from December 8 to December 14, 2016. This was the firm's initial comprehensive inspection. The inspection meticulously reviewed Access Biologicals' quality systems, encompassing Quality Assurance, Product Testing, Quarantine/Inventory Management, Product Processing, and aspects related to Donor Eligibility for their plasma sources. The regulatory framework for the inspection centered on compliance with standards applicable to blood and blood product manufacturers, ensuring product quality and safety. Notably, the inspection report indicates no major deviations or significant issues were identified. Review of temperature monitoring records found no major discrepancies, and the firm's complaint processing procedures, internal error reporting, and CAPA systems were also assessed. There were no refusals during the inspection, and no samples were collected. As a result of the inspection revealing no regulatory violations or findings, no specific required actions were issued by the FDA to Access Biologicals LLC. This outcome suggests the company demonstrated satisfactory adherence to relevant manufacturing and quality standards at the time of the inspection.