On October 17, 2024, the U.S. Food and Drug Administration (FDA) revealed that it had identified several violations at Humacyte's North Carolina manufacturing facility. These findings were detailed in a Form 483 issued by the agency.
The violations included a lack of microbial quality assurance and microbial testing, alongside inadequate quality oversight. These issues raise concerns regarding the facility's adherence to good manufacturing practices.
Such regulatory observations can impact the ongoing review of Humacyte's Biologic License Application for its acellular tissue engineered vessel (ATEV) and may require remediation efforts to address the identified deficiencies.
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