FDA 483 - B Positive National Blood Services - Wyoming, LLC. - February 02, 2026

Between January 28 and February 2, 2026, the Food and Drug Administration (FDA) conducted an inspection of B Positive National Blood Services Wyoming, LLC, a source plasma donor center located in Wyoming, Pennsylvania. The inspection was carried out under the authority of the Federal Food, Drug, and Cosmetic Act to ensure the facility meets safety and operational standards for blood component collection and processing. The investigator identified three primary areas of concern. First, the facility failed to maintain concurrent documentation for product distribution, specifically missing records for biohazard waste management pickups. Second, the center lacked comprehensive written standard operating procedures for managing internal deviations and incidents. There was no formal process or guidance for investigating issues reported by staff involved in donor registration and screening, leading to a breakdown in quality oversight. Finally, the facility failed to manage medical supplies appropriately; investigators discovered approximately ten boxes of expired gloves stored near the active inventory without any signage to prevent staff from using them. These observations indicate that the firm is not fully compliant with the required protocols for record-keeping and procedural management. Although these findings do not represent a final agency determination, the management at B Positive National Blood Services is expected to address these deficiencies. The company must either discuss their planned corrective actions with the FDA representative or submit a formal response detailing their remediation steps to the FDA"s Philadelphia District Office. Ensuring that all steps in the collection and distribution process are documented and that staff follow clear, written guidelines is essential for maintaining product safety and regulatory compliance.