FDA 483 - Millipore (U.K.) Ltd. - February 27, 2020

An FDA inspection of Millipore (U.K.) Ltd., a licensed bulk blood grouping reagent manufacturer in Livingston, United Kingdom, revealed two significant observations. The firm was cited for releasing licensed products before completing conformity tests, specifically regarding sodium azide content, and for failing to maintain adequate records to trace manufacturing steps, including unreviewed calculations and assessments in batch records.