Lux Therapeutics LLC dba Ponya Therapeutics LLC

During an inspection of your firm, Lux Therapeutics LLC dba Ponya Therapeutics LLC located at 13 Corporate Blvd NE, Brookhaven, GA, conducted between June 2, 2025, and June 6, 2025, the United States Food and Drug Administration (FDA) documented significant violations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations (21 CFR) Part 1271 (21 CFR 1271) and issued under the authority of Section 361 of the Public Health Service Act [42 U.S.C. § 264].1

The observations documented on the Form FDA-483, List of Inspectional Observations (FDA 483), were presented to and discussed with you at the conclusion of the inspection, and following FDA’s review, your violations include, but are not limited to, the following:

1) Failure to validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests. The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation [21 CFR 1271.230(a)]. For example, you failed to validate the manufacturing process for your dehydrated, dual layer amniotic membrane patch, TheraMend, which cannot be fully verified, to ensure that your process does not cause contamination or cross-contamination and prevents the introduction, transmission or spread of communicable disease through the use of the HCT/P. Since August 2023, your firm has processed TheraMend products and distributed those products without a validated process.

2) Failure to provide a summary of records to accompany an HCT/P, that contains a listing and interpretation of the results of all communicable disease tests performed [21 CFR 1271.55(b)(2)]. Specifically, a listing and interpretation of the results of all communicable disease tests is not included on the Notification of Requirements to Maintain Traceability of Human Tissue-Based Products or Instructions for Use and Product Information forms, which are considered accompanying records as described in 21 CFR 1271.55(a).

The violations identified above are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment complies with all applicable federal regulations. You are responsible for reviewing your firm’s operations, including firms within the same organization, as a whole to ensure that you are in compliance with the law.

We acknowledge receipt of your email correspondence submitted on June 30, 2025, responding to the inspectional observations. We have reviewed your response, and we have determined that the response is inadequate to address our concerns. We have the following comments regarding your FDA 483 response:

• In response to Observation 1, you state that you discontinued manufacturing your Luxegen product, derived from human umbilical cord tissue, but will continue distributing Luxegen until December 1, 2025. We remain concerned about the Luxegen product that you previously distributed as well as your continued distribution of this product given its lack of approval as well as the conditions under which it was manufactured, as described in the FDA-483. 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.

• In response to Observation 4a, you stated “Validation planning will being [sic] in July 2025 with all process validation activities anticipated to be completed by the end of Q2 2026.” Your response does not indicate that you will halt distribution of TheraMend products until your process has been validated. Your response also does not indicate any planned actions for the TheraMend products that have already been distributed.

Additionally, your response states, “Regarding product in the field, to date, we have not received any product complaints or adverse events. Similarly, 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.” This justification is insufficient. You are required to validate your process to ensure that processing prevents the introduction, transmission, or spread of communicable disease through use of the HCT/P. It is your responsibility to ensure you validate all processing activities for the product(s) you are manufacturing.

• In response to Observation 7, we acknowledge your commitment to revise procedures and retrain staff on the required summary of records as part of your CAPA #CPAR25-010. Please also ensure that a statement whether, based on the results of screening and testing, the donor has been determined to be eligible or ineligible accompanies your HCT/P at all times once a donor-eligibility determination has been made in accordance with 21 CFR 1271.55(a)(2).

You should take prompt action to correct any violations addressed in this letter and prevent their recurrence. Failure to promptly correct any violations may result in regulatory action being initiated by FDA without further notice.

Your written response should be sent to the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Avenue, WO71-G112, Silver Spring, MD 20993-0002. Please also email your response to CBERDCMRecommendations@fda.hhs.gov.

If you have any questions regarding this letter, please contact CBER’s Division of Case Management at CBERDCMRecommendations@fda.hhs.gov. Please be advised that only written communications are considered official.