Chara Biologics, Inc.

Warning LetterOpen

Joy Kong, M.D. Chief Executive Officer Chara Biologics, Inc. 9568 Topanga Canyon Blvd., Suite 104 Chatsworth , CA 91311 United States (b)(6)FEI 3015265204Issued Jan 17, 2025Center for Biologics Evaluation and Research (CBER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3015265204.

Violations11

Issue DateJan 17, 2025

Product TypeBiologics

StatusOpen

Letter Details

Firm: Chara Biologics, Inc.
Location: Joy Kong, M.D. Chief Executive Officer Chara Biologics, Inc. 9568 Topanga Canyon Blvd., Suite 104 Chatsworth , CA 91311 United States (b)(6)
FEI Number: 3015265204
Country: United States
Issue Date: January 17, 2025
Issuing Office: Center for Biologics Evaluation and Research (CBER)
Product Type: Biologics
Status: Open

Summary

Chara Biologics, Inc. was warned for manufacturing and distributing three unapproved biological products—CharaExo (human amniotic fluid) and CharaCore and CharaOmni (cellular products derived from human umbilical cord)—without a biologics license application (BLA) approval or new drug application (NDA), in violation of the Public Health Service Act and Federal Food, Drug, and Cosmetic Act. An FDA inspection conducted between July 23 and August 16, 2024, identified significant violations of current good manufacturing practice (CGMP) and current good tissue practice (CGTP) requirements under 21 CFR parts 210 and 211. The company's introduction and distribution of these unlicensed products into interstate commerce was prohibited under federal law.

Chara Biologics, Inc. FDA Warning Letter, January 17, 2025