FDA 483 - Soleva Pharma Llc - March 04, 2025
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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.
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ID · 189b2001-ccbe-4b7d-889e-50c26d3d1634