FDA EIR - Umicore Nederland B.V. - November 24, 2014

An abbreviated surveillance inspection of Umicore Nederland B.V., an active pharmaceutical ingredient manufacturer, was conducted by the FDA from November 24 to 27, 2014. This inspection utilized compliance program 7356.002F as guidance for evaluating operations. The current inspection covered Quality, Production, and Laboratory systems, and importantly, concluded with no FDA Form 483, Inspectional Observations, being issued. The proposed classification was "No action indicated," with final recommendation pending from the center. A minor administrative finding during this visit was that the firm's drug listing and registration had expired on December 31, 2013, which the company promptly updated on November 26, 2014. The firm also reported no recalls and noted voluntary corrections implemented since 2011. This contrasts significantly with a previous inspection in May 2005, which resulted in a "Voluntary Action Indicated" classification and a six-item FDA Form 483. Past violations included deficiencies in raw test data retention, lack of stability protocols and impurity profiles, absence of out-of-specification procedures, unapproved master batch records, and inadequate laboratory instrument documentation. The current inspection's favorable outcome suggests substantial improvements have been made since the prior assessment.