FDA 483 - Prodose, Inc. - January 25, 2017

An FDA inspection of Spirit Pharmaceuticals, a pharmaceutical packager and distributor in Ronkonkoma, NY, revealed significant deficiencies in its quality control unit and equipment maintenance. Observations included failures in packaging line qualification, inadequate investigation of product complaints regarding cloudiness/crystallization, and incomplete employee training records. Additionally, the firm's routine checking of metal detectors on packaging lines was found to be deficient, lacking non-ferrous metal challenges.