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

Source: https://www.keypedia.com/records/warning_letter/invitrx-therapeutics-inc/460f9034-1524-4320-84f4-f6f2f034a687

> FDA WARNING_LETTER for Invitrx Therapeutics, Inc. on March 22, 2022. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Invitrx Therapeutics, Inc.
- Inspection Date: 2022-03-22
- Product Type: Biologics
- Office Name: Division of Biological Products Operations II
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

Company: https://www.keypedia.com/companies/invitrx-therapeutics-inc/56e1511c-e350-4897-bd61-a11300012528

Office: https://www.keypedia.com/offices/division-of-biological-products-operations-ii/a2187202-a132-4872-9ff9-2b97ae88ed9f