Lux Therapeutics LLC dba Ponya Therapeutics LLC
FDA issued a warning letter to Lux Therapeutics LLC dba Ponya Therapeutics LLC (Brookhaven, GA) following a June 2025 inspection that found significant violations of 21 CFR Part 1271 governing human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to validate its manufacturing process for its dehydrated dual-layer amniotic membrane patch (TheraMend) and failed to include required communicable disease test summaries with distributed products. FDA found the firm's corrective responses inadequate, particularly its plan to continue distributing TheraMend without a validated process, and demanded a written response within 15 working days outlining corrective actions or face further regulatory action.
Flagged claims (1)
the product has a straightforward manufacturing process, and an approximately 99.99% change of passing validation. It is intended as a protective covering, so we believe any product in the field is safe and of a quality manner.
Required actions (3)
We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct any violations, including an explanation of how you plan to prevent them, or similar violations, from occurring again.
We ask that you respond to this letter with your plans for addressing the Luxegen product that remains in the marketplace, within expiry, as well as confirmation that you have ceased distribution by December 1, 2025, and documentation demonstrating that you have done so.
Failure to promptly correct any violations may result in regulatory action being initiated by FDA without further notice.
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