FDA EIR - Umicore Nederland B.V. - November 26, 2014

An FDA abbreviated surveillance inspection of Umicore Nederland B.V., an active pharmaceutical ingredient (API) manufacturer, took place from November 24 to November 27, 2014. Conducted under compliance program 7356.002F, the inspection assessed Quality, Production, and Laboratory systems. Significantly, no FDA 483, which details inspectional observations, was issued during this inspection. This led to a proposed classification of "No action indicated," with further follow-up to be determined by the Center for Drug Evaluation and Research (CDER). The inspection report noted that the firm had updated its expired drug registration during the visit. While no violations were identified in this latest review, a previous inspection in May 2005 had resulted in a "Voluntary Action Indicated" classification and a six-item FDA 483. Those historical observations included concerns regarding the retention of raw test data, absence of stability testing protocols, lack of documented procedures for handling out-of-specification results, unapproved master batch records, and inadequate documentation for instrument maintenance and calibration. The current findings indicate compliance, with no required actions other than awaiting CDER's final recommendation.