Mekonnen Abebe
Owner and Chief Executive Officer
Lux Therapeutics LLC dba Ponya Therapeutics LLC
13 Corporate Blvd NE
Brookhaven , GA 30329
United States
MAbebe@ponyadx.comFEI 3024253503Issued Nov 25, 2025Office of Compliance and Biologics Quality
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3024253503.
Violations3
Issue DateNov 25, 2025
Product TypeBiologics
StatusOpen
Letter Details
Firm
Lux Therapeutics LLC dba Ponya Therapeutics LLC
Location
Mekonnen Abebe
Owner and Chief Executive Officer
Lux Therapeutics LLC dba Ponya Therapeutics LLC
13 Corporate Blvd NE
Brookhaven , GA 30329
United States
MAbebe@ponyadx.com
FEI Number
3024253503
Country
United States
Issue Date
November 25, 2025
Issuing Office
Office of Compliance and Biologics Quality
Product Type
Biologics
Status
Open
Summary
Lux Therapeutics LLC (doing business as Ponya Therapeutics LLC) was cited for significant regulatory violations related to its TheraMend dehydrated dual-layer amniotic membrane patch, a human cellular and tissue-based product (HCT/P). The company failed to validate its manufacturing process for TheraMend despite processing and distributing the product since August 2023, and failed to provide adequate communicable disease testing records and interpretations as required by FDA regulations for HCT/Ps. These violations were documented during an FDA inspection conducted in June 2025 at the company's Brookhaven, Georgia facility and violated Title 21 CFR Part 1271 requirements under the Public Health Service Act.
Lux Therapeutics LLC dba Ponya Therapeutics LLC FDA Warning Letter, November 25, 2025
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