FDA 483 - Takeda Austria GmbH - November 05, 2018

An FDA inspection of Takeda Austria GmbH in Linz, Austria, a biologics manufacturer of Fibrin Sealant Patch (TachoSil), revealed multiple deficiencies. Observations included incomplete qualification of incoming materials, lack of extractables/leachables studies, and inadequate procedures for complaint processing, adverse events, and packaging. Furthermore, the firm lacked established timeframes in SOPs and Quality Agreements for product recalls and returns, and demonstrated insufficient oversight of its contracted distributor.