FDA 483 - Biomat USA, Inc. - December 13, 2024

An FDA inspection conducted at Biomat USA, Inc., a Source Plasma Center located in Terre Haute, IN, from December 10 to December 13, 2024, resulted in the issuance of a Form FDA 483. This document outlines observations of conditions and practices that indicate potential non-compliance with regulatory requirements. The primary finding centered on the company's failure to consistently adhere to its own written standard operating procedures (SOPs) for the collection of blood and blood components. Specifically, an investigator observed a phlebotomist failing to verbally verify the full name and donor number of plasmapheresis donors prior to venipuncture, which is a critical step outlined in SOP PC-001. Additionally, during the inspection, it was noted that an operations supervisor and a quality systems manager did not properly obtain immediate proof of address for an applicant donor. Instead, they opted to mail a postcard to the donor's new address, deviating from SOP DE-014 regarding donor address verification. These observations highlight deficiencies in procedural adherence and quality control within Biomat USA, Inc.'s operations. While the FDA 483 itself is not a final determination of non-compliance, it necessitates the firm's review of these issues and the implementation of appropriate corrective actions to ensure full compliance with FDA regulations and their internal quality systems for the collection of plasma for further manufacturing.