FDA 483 - Warner Graham LLLP - May 21, 2024

An FDA inspection of Warner Graham LLLP in Cockeysville, MD, a repacker and manufacturer, revealed significant deficiencies across its operations. The firm failed to establish adequate production and process controls, quality control unit procedures, and equipment cleaning protocols. Additionally, issues were noted with microorganism prevention, master production records, and the absence of a stability testing program for drug products.