FDA 483 - Biomat USA Inc - February 04, 2026

Biomat USA Inc., a source plasmapheresis collection center in Surprise, Arizona, underwent an FDA inspection from January 27 through February 4, 2026. The inspection, conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, identified three primary areas of non-compliance regarding donor safety and record-keeping. First, the facility failed to maintain complete donor history records. The center relied on qualitative interpretations (e.g., "Normal" or "Abnormal") for total protein levels rather than quantitative results, and medical specialists failed to review these values when determining donor eligibility. Second, staff repeatedly failed to follow standard operating procedures during donor preparation. Inspectors observed multiple instances where phlebotomists did not adhere to required arm-scrubbing techniques or mandatory drying times before performing venipuncture, which is critical for preventing contamination. Finally, the facility"s procedures for investigating adverse donor reactions were found to be inadequate. A specific case involving a centrifuge spill that resulted in a donor"s hospitalization was not thoroughly investigated; the center failed to document interviews with the staff involved or perform a root-cause analysis of the improper equipment setup. This report serves as a preliminary list of observations rather than a final agency determination. Biomat USA Inc. is expected to respond to these findings by discussing objections or submitting a formal plan for corrective actions to the FDA to ensure future compliance with health and safety regulations.