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Lux Therapeutics LLC (doing business as Ponya Therapeutics LLC) was cited for significant regulatory violations related to its TheraMend dehydrated dual-layer amniotic membrane patch, a human cellular and tissue-based product (HCT/P). The company failed to validate its manufacturing process for TheraMend despite processing and distributing the product since August 2023, and failed to provide adequate communicable disease testing records and interpretations as required by FDA regulations for HCT/Ps. These violations were documented during an FDA inspection conducted in June 2025 at the company's Brookhaven, Georgia facility and violated Title 21 CFR Part 1271 requirements under the Public Health Service Act.