483
Terumo BCT LtdTerumo BCT Ltd – FDA 483, Jun 26, 2026
Record Details
An FDA inspection of Terumo BCT Ltd, a biological drug manufacturer in Larne, United Kingdom, revealed two significant observations related to laboratory control. The firm failed to adequately document calculations for final product release testing and did not consistently record or investigate deviations from written specifications, impacting drug products distributed to the United States.
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ID · 972b3d7b-62fc-45c2-a678-81aa72b6b558
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