FDA 483 - Stason Pharmaceuticals, Inc. - April 13, 2021

An FDA inspection of Stason Pharmaceuticals, Inc. in Irvine, CA, revealed two significant observations related to quality system deficiencies. The firm was cited for inadequate employee training, specifically failing to provide follow-up training after identifying a trend of human errors. Additionally, the quality control unit lacked written procedures, particularly concerning the evaluation and assessment of an outside contract lab used for microbiological testing.