Unauthorized Drugs and Biological Products from Chara Biologics, Inc.

The FDA conducted an inspection of Chara Biologics, Inc. from July 23, 2024, through August 16, 2024, and found that the company manufactures and distributes the following products:

• CharaExo: A product from human amniotic fluid

• CharaCore: A cellular product from human umbilical cord
• CharaOmni: Another cellular product from human umbilical cord

These products are offered for allogeneic use, i.e. they are intended for use on individuals other than the donor.

Violations of the FD&C Act and the PHS Act

The FDA determined that the above drugs are classified as biologics. A valid Biologics License Application (BLA) approved by the FDA is required to market such products. However, Chara Biologics, Inc. does not have such approval for these products, making them in violation of the FD&C Act and the PHS Act.

Violations of Good Manufacturing Practice (CGMP) and Good Tissue Practice

In addition, serious violations of Good Manufacturing Practice (CGMP) and Good Tissue Practice (CGTP) were identified. These include the lack of a quality assurance system, deficient production and process controls, inadequate documentation of donor data and the extension of expiry dates without scientific evidence. Due to these deficiencies, the products are considered to be adulterated and misleadingly labeled. These violations can also impair the safety, purity and efficacy of the products.

The FDA is requiring Chara Biologics, Inc. to submit a written explanation of corrective actions taken or planned within 15 business days. Otherwise there is a risk of legal action, including product seizures and cease and desist orders. The company has a responsibility to ensure that all products comply with regulatory requirements to ensure the health and safety of consumers.

Read the full Warning Letter from Chara Biologics on the official FDA website.