Invitrx Therapeutics, Inc.
FDA issued a Warning Letter to Invitrx Therapeutics, Inc. (Lake Forest, CA) following a March 2022 inspection documenting that the company manufactured and distributed unapproved biological products — including a human umbilical cord-derived mesenchymal stem cell product (Invitra UC-MSC™) and exosome products (Invitra EX™ and Invitra EV-OP™) — without an approved Biologics License Application or an active IND, in violation of the FD&C Act and PHS Act. The letter also cited extensive CGMP and CGTP deviations including unvalidated aseptic processes, deficient donor eligibility determinations, inadequate sterility testing, and failure to investigate adverse event complaints. This was a repeat action following a March 2020 Warning Letter for the same firm, and FDA warned that failure to adequately respond could result in seizure and/or injunction.
Flagged claims (4)
you have assigned two-year expiration dates to your exosome products without supporting data
exosome products, marketed for the treatment of diseases and conditions in humans
using this product to treat orthopedic conditions, such as osteoarthritis, for example, is not homologous use as defined in 21 CFR 1271.3(c)
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.
We also request your attendance at a Regulatory Meeting to discuss the status of the specific steps you have taken since the inspection to address any violations.
Failure to adequately address these matters may lead to regulatory action without further notice. Such actions may include seizure and/or injunction.
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