FDA 483 - Humacyte Global Inc - April 05, 2024

Humacyte Global, Inc. in Durham, NC, a drug product manufacturer, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in microbial quality assurance for a component used in drug product formulation and inadequate quality oversight, including issues with out-of-specification investigations, training for cleaning personnel, and documentation for preventative maintenance. These findings indicate significant concerns regarding the firm's quality control and adherence to cGMPs.