FDA 483 - TriRx Huntsville Pharmaceutical Services, LLC - December 19, 2014

An FDA inspection of Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals in Huntsville, AL, identified a significant quality control deficiency. The firm failed to reject finished drug product batches that did not meet established in-process specifications. Additionally, reprocessing of these non-conforming batches was not performed, indicating a serious lapse in product quality assurance.