FDA 483 - US Specialty Formulations LLC - January 14, 2026

US Specialty Formulations LLC, an outsourcing facility in Allentown, PA, was inspected and cited for significant deficiencies across its quality control, analytical testing, stability programs, and sterile manufacturing processes. The inspection revealed a lack of scientifically sound specifications, unvalidated test methods, inadequate stability data, and failures in preventing microbiological contamination for its Sarracenia Purpurea 0.17 g/mL for Injection product. These issues indicate a systemic failure to ensure the identity, strength, quality, and purity of its drug products.