Kimera Labs, Inc.
FDA issued a Warning Letter to Kimera Labs, Inc. (Miramar, FL) regarding its exosome products XoGlo®, XoGlo®Pro, and amniotic fluid product Amnio2X®, which were manufactured and distributed without an approved Biologics License Application (BLA) or valid IND, constituting unapproved biological drug products under the FD&C Act and PHS Act. The inspection uncovered at least 10 significant CGMP violations affecting over 37,000 vials, including failures in aseptic process validation, sterility testing, environmental monitoring, and laboratory controls. FDA noted that Kimera continued distributing products after a prior 2020 Untitled Letter put them on notice, and that serious adverse events had been reported in patients treated with exosome products. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure and/or injunction.
Flagged claims (3)
a sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe and effective for the purposes for which it is under investigation or otherwise promote the drug
treatment of skin damage after cosmetic or other facial injury by heat, light, physical, or chemical damage
your products are intended to treat various diseases or conditions
Required actions (3)
We request that you respond in writing within fifteen (15) working days from your 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 may include seizure and/or injunction.
Such actions may include seizure and/or injunction.
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