FDA WARNING_LETTER - Lux Therapeutics LLC - June 06, 2025

The FDA issued a Warning Letter to Lux Therapeutics LLC dba Ponya Therapeutics LLC following an inspection conducted between June 2 and June 6, 2025. The inspection revealed significant violations of the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271. Key violations include the company"s failure to validate the manufacturing process for its dehydrated, dual-layer amniotic membrane patch, TheraMend. This process, which commenced in August 2023, was not validated to ensure it prevents contamination or the spread of communicable diseases. Additionally, the company failed to provide a complete summary of records accompanying HCT/Ps, specifically lacking a listing and interpretation of all communicable disease test results as required. The FDA deemed the company"s June 30, 2025, response inadequate. Concerns were raised regarding the continued distribution of TheraMend without a validated process and the lack of a plan for products already distributed. The FDA also requested further details on plans for the previously distributed Luxegen product and confirmation of its distribution cessation by December 1, 2025. Lux Therapeutics LLC is required to take prompt action to correct all violations, prevent recurrence, and submit a written response within fifteen working days. This response must detail specific corrective actions, prevention plans, and supporting documentation, including addressing distributed products and ensuring proper donor eligibility statements accompany HCT/Ps.