Stason Pharmaceuticals, Inc. – FDA 483, Oct 25, 2019

An FDA inspection of Stason Pharmaceuticals, Inc. in Irvine, CA, revealed significant deficiencies in manufacturing and quality control processes. The firm failed to ensure proper drug product testing, stability data, and thorough investigations into out-of-specification results and complaints. Issues also included inadequate contamination control, improper gowning, and compromised data integrity in laboratory systems.