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Investigation into Humacyte continues after FDA cites manufacturing violations and lawsuit proceeds.

Market News
21 Aug 2026
PRNewsWire
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Bearish
Investigation into Humacyte continues after FDA cites manufacturing violations and lawsuit proceeds.

Kahn Swick & Foti, LLC is investigating Humacyte, Inc. following the FDA's inspection that revealed serious violations at Humacyte's manufacturing facility, including lack of microbial quality assurance and testing. The FDA delayed approval of Humacyte's Biologic License Application for its acellular tissue engineered vessel product. Additionally, a securities class action lawsuit accusing the company and its executives of failing to disclose material information is moving forward after a court denied part of the company's dismissal motion. The investigation focuses on potential breaches of fiduciary duty and legal violations by Humacyte's officers and directors.

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