FDA 483 - Humacyte Global Inc - April 05, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 55cd417b-c6b6-4489-9066-3488ed2f9a20