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

• Pharma GMP
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