RenatiLabs Inc.
FDA issued a warning letter to RenatiLabs Inc. (Erlanger, KY) following an August 2022 inspection of their manufacture and distribution of WJMAX™, a Wharton's jelly/umbilical cord-derived product intended for allogeneic intra-articular injection and wound treatment. FDA determined WJMAX™ is an unapproved biological drug product lacking a valid biologics license application (BLA) or investigational new drug (IND) application, and that it fails the homologous use and minimal manipulation criteria under 21 CFR 1271.10(a). The agency also documented serious CGMP violations including release of a lot that failed sterility testing due to Staphylococcus epidermidis contamination, lack of aseptic process validation, and unsupported four-year expiration dating. FDA warned that failure to adequately respond may result in seizure and/or injunction.
Flagged claims (3)
intended to be administered by intra-articular injection or topically to open wounds and purports to be sterile
your product is intended to treat various diseases or conditions
RenatiLabs is committed to adhere to the compliance regime to process and deliver tissue products under section 361 of the FDA compliance regulations
Required actions (3)
We request that you respond in writing within fifteen (15) working days of receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions include seizure and/or injunction.
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