FDA 483 - US Specialty Formulations LLC

An FDA inspection of US Specialty Formulations LLC, conducted from January 5-14, 2026, identified seven significant observations regarding the manufacture of drug products, primarily Sarracenia Purpurea 0.17 g/mL for Injection. The regulatory framework for these observations highlights critical deviations from established quality and manufacturing controls.

Key violations included a deficient quality control unit that failed to establish scientifically sound specifications, ensure proper testing for finished products and bulk materials (e.g., identity, pH, assay, impurities), and adequately support retest dates. This unit also permitted an unauthorized relabeling activity, with several of these quality control issues noted as repeat observations from previous inspections.

Furthermore, the firm lacked validated and stability-indicating test methods, leading to an inability to identify potential degradants and ensure product stability. A robust stability testing program was absent, resulting in unsupported product expiry dates and improper storage of stability samples. Procedures to prevent microbiological contamination were not adequately established or followed, impacting visual inspection processes, personnel qualification, process validation for filling operations, and container closure integrity. Discrepancies were also noted in sterilization equipment qualification, another repeat observation.

Additional issues included inadequately designed or unqualified manufacturing equipment (e.g., balance, autocapper, label printer), and the acceptance of supplier certificates of analysis for vial stoppers without independent verification of reliability. Drug products, specifically Sarracenia Purpurea Bulk Distillate, were not stored under appropriate, temperature-monitored conditions. These observations require the company to implement comprehensive corrective actions to ensure compliance with drug manufacturing regulations.