FDA 483 - US Specialty Formulations LLC - March 26, 2025

US Specialty Formulations LLC, an Allentown, PA manufacturer, was cited for significant deficiencies in its production, laboratory, and quality control processes during an FDA inspection. The observations highlight a lack of validation for manufacturing processes, analytical methods, and cleaning procedures, particularly concerning Sarracenia Purpurea Bulk Distillate. Additionally, the firm failed to adequately test components and maintain proper written procedures for its quality control unit.