FDA 483 - Lux Therapeutics LLC - June 06, 2025

Lux Therapeutics LLC dba Ponya Therapeutics LLC in Brookhaven, GA, was cited for significant deficiencies in its manufacturing processes for drug products and human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed a lack of validated manufacturing and cleaning processes, inadequate product testing, and failures to follow established procedures for HCT/P manufacturing and stability testing. Additionally, the firm did not include donor-eligibility summaries with distributed HCT/Ps.