FDA WARNING_LETTER - Invitrx Therapeutics, Inc. - March 22, 2022

The FDA issued a Warning Letter to Invitrx Therapeutics, Inc. on November 9, 2022, following an inspection from March 1-22, 2022. The inspection revealed that Invitrx manufactures and distributes unapproved cellular and exosome products (Invitra UC-MSC™, Invitra EX™, Invitra EV-OP™) for allogeneic use, intended to be sterile and treat various conditions. These products are classified as unapproved drugs and biological products under the FD&C Act and PHS Act, requiring a valid biologics license or an Investigational New Drug (IND) application, neither of which Invitrx possesses.

Specifically, Invitra UC-MSC™ fails to meet the homologous use and minimal manipulation criteria for HCT/Ps, subjecting it to drug and biologic regulations. The letter also highlights significant, repeat deviations from Current Good Manufacturing Practice (CGMP) and Current Good Tissue Practice (CGTP), including: * Failure to determine and document donor eligibility for hundreds of tissue donors. * Inadequate aseptic processing validation, including improper storage of sterile components and insufficient environmental monitoring. * Unvalidated in-house sterility testing methods and inadequate sample numbers. * Lack of validated manufacturing processes and appropriate product specifications. * Failure to test components and closures before use. * Absence of stability data to support assigned expiration dates. * Failure to investigate product complaints, including adverse events