FDA 483 - Salvona Technologies, LLC - October 18, 2024

Salvona Technologies, LLC in Hamilton, NJ, was inspected by the FDA, revealing significant deficiencies across its manufacturing and quality control operations. The firm failed to establish adequate written procedures for process validation, equipment qualification, cleaning, stability testing, and quality control unit responsibilities. These issues indicate a broad failure to ensure the identity, strength, purity, and quality of their drug products.