FDA 483 - Lux Therapeutics LLC - June 06, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · fdef8e64-3c55-4528-b7d0-fd73f7965265