FDA 483 - Takeda Pharamaceutical Company Limited - June 06, 2025

An FDA inspection conducted at Takeda Pharmaceutical Company Limited's Longmont, CO Source Plasma Center from June 2-6, 2025, revealed significant issues with equipment standardization and calibration practices. The observations, reported under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlight a lack of adherence to established operational procedures and manufacturer guidelines for critical equipment used in blood and blood component collection and processing. Specifically, the inspection noted two instances of non-compliance. First, an employee failed to properly perform quality control checks on plasmapheresis machines, neglecting to tare the weigh scale before testing with calibrated weights, a step explicitly required by the firm's standard operating procedure and the operator's manual. Second, a review of records indicated that a plasma protein refractometer, essential for daily quality control, was not handled correctly after an out-of-range test result. Instead of removing the instrument from service and contacting a representative as instructed by the manufacturer's guide, an employee repeatedly re-tested until an "in-range" result was achieved, then approved the instrument for use. These observations necessitate prompt corrective actions by Takeda to ensure compliance with regulatory standards and the integrity of their plasma collection processes.