FDA EIR - Access Biologicals Llc - August 21, 2019

An FDA inspection of Access Biologicals LLC, a registered blood establishment in Vista, CA, was conducted from August 19-21, 2019. This routine Level 2 inspection, part of the Office of Biological Products Operations Workplan, assessed the company's compliance with regulatory guidance CP 7342.002 and CP 7342.001. The scope included Quality Assurance, Product Collection and Processing, and Quarantine/Storage/Disposition systems. Access Biologicals specializes in manufacturing custom biological products for diagnostic use, utilizing licensed and unlicensed Normal and Disease State Source Plasma. The inspection focused on areas such as FDA Blood Establishment Registration, records and procedures for frozen storage, manufacturing records for pooled donor plasma, product traceability from bleed number to distribution, and labeling. Importantly, the inspection concluded with no observations or issues identified by the FDA investigator. No FDA Form 483 was issued, indicating full compliance with the regulatory framework reviewed. As a result, no specific violations were found, and therefore, no corrective actions were required from Access Biologicals LLC following this inspection.