FDA WARNING_LETTER - Invitrx Therapeutics Inc. - April 03, 2019

On March 16, 2020, the FDA issued a Warning Letter to Invitrx Therapeutics, Inc. following an inspection from March 25 to April 3, 2019. The inspection revealed that Invitrx processes and distributes allogeneic products, including human umbilical cord blood, umbilical cord-derived products (Invitra CBSCTM, Invitra WJTM), amniotic fluid-derived product (Invitra AFTM), and amniotic membrane-derived product (Invitra ATTM). These products are intended for injection and purported to be sterile, marketed for various conditions, thus classifying them as drugs and biological products under the FD&C Act and PHS Act. Some are also HCT/Ps.

Invitrx's products do not qualify for exceptions under 21 CFR 1271.15 and fail to meet criteria in 21 CFR 1271.10(a), specifically regarding homologous use, minimal manipulation, and metabolic activity. Consequently, they are regulated as drugs and biological products requiring an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application, neither of which Invitrx possesses.

The inspection also identified significant deviations from Current Good Manufacturing Practice (CGMP) and Current Good Tissue Practice (CGTP), posing safety concerns due to potential contamination. Deficiencies include: - Failure to determine and document donor eligibility (21 CFR 1