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# 2 Firms Illegally Selling Biologics: FDA
- URL: https://www.fdaweb.com/2-firms-illegally-selling-biologics-fda/
- Published: 2025-01-28T12:00:00.000Z
- Updated: 2026-09-14T14:51:51.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158555

FDA says its review of a Web site maintained by Evolutionary Biologics in New York, NY, and its inspection at Chara Biologics in Chatsworth, CA, determined that the firms are selling unlicensed biologic products that are legally considered to be unapproved new drugs. A just-released 12/30/2024 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evolutionary-biologics-inc-681586-12302024?ref=fdaweb.com) to Evolutionary says the firm markets exosome, umbilical cord, and cellular products derived from umbilical cord, placenta tissue, and amniotic membrane. The letter says the products are not the subject of a required approved BLA or approved application under Section 505 of the Federal Food, Drug, and Cosmetic Act.

Evolutionary was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, including documentation necessary to show that the matters have been addressed, with a schedule for completing the corrections.

The letter also expresses the agency’s concerns with other products on the firm’s Web site and says FDA has determined that these products also do not have an approved BLA.

A 1/17 Warning Letter to [Chara](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chara-biologics-inc-698004-01172025?ref=fdaweb.com) says the firm manufactures and distributes a human amniotic fluid product and cellular products derived from human umbilical cord for allogeneic use. In addition to noting the lack of an approved BLA for the unapproved new drugs, the letter summarizes these significant violations of current good manufacturing practice (CGMP) requirements:

- failure to establish a quality unit with the responsibility and authority to approve or reject all labeling and drug products, and failure to have and follow written responsibilities and procedures for the quality control unit; and
- failure to maintain documentation of the determination of donor eligibility, including the name of the responsible person who made the determination and the date of the determination.

The letter also says one of the firm’s products is misbranded because the labeling extended the expiration date without supporting data. It says the firm’s responses do not adequately address the agency’s concerns about the status of Chara’s manufacturing and distribution operations or its specific plans for disposition of products that were manufactured under conditions described in the letter.

An 11/25/2019 FDA letter indicated that based on an evaluation of the firm’s Web site, it appeared that Chara was illegally marketing a biologic product. The company was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation showing that the matters have been addressed and a schedule for completing the corrections.