FDA 483 - Soleva Pharma Llc - March 04, 2025

An FDA inspection of Soleva Pharma Llc, a specification developer in Robbinsville, NJ, revealed significant deficiencies across multiple areas. The firm failed to adequately establish design verification procedures for its MuGard® product's extended shelf life, lacked proper complaint handling for four patient deaths, and did not label its medical device with the required unique device identifier. These observations indicate serious non-compliance with medical device regulations.