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FDA Warns Chara Biologics Over Unapproved and Adulterated Products

FDA Warns Chara Biologics Over Unapproved and Adulterated Products

The FDA inspected Chara Biologics, Inc. (July 23 – Aug. 16, 2024) and found violations related to its biologic products:

  • CharaExo (from human amniotic fluid)
  • CharaCore (cellular product from human umbilical cord)
  • CharaOmni (cellular product from human umbilical cord)

Regulatory Violations:

  • Unapproved Biologics: These drugs require an FDA-approved Biologics License Application (BLA), which the company lacks.
  • Manufacturing Violations: Serious deficiencies in Good Manufacturing Practice (CGMP) and Good Tissue Practice (CGTP) were identified, including:
    • No quality assurance system
    • Poor production controls
    • Inadequate donor data documentation
    • Unjustified expiry date extensions

The FDA has demanded corrective actions within 15 business days to avoid legal consequences such as product seizures or a cease-and-desist order.

Read the full FDA Warning Letter on the agency’s official website.

31-03-2025