FDA discloses summary of violations at Humacyte’s Durham, NC facility

The U.S. Food and Drug Administration disclosed in a form 483 summary a number of violations found at Humacyte’s (HUMA) Durham, North Carolina facility. According to an inspection performed earlier thtis year, quality oversight at the facility is “inadequate” for a number of issues, including: the existence of 10 out of 31 out-of-specification investigations that were open for more than 100 days, with the longest being open for 710 days; the contract cleaning crew not being current with their cGMP Refresher Training as required by the Training Program, with one member of the cleaning crew not current on the GxP Cleaning Contractor Core Trainign “Facility Cleaning and Disinfection”; a lack of a complete record for the role-based training for an operator, and; the quality review of the preventative maintenance of the air handling unit being approved without the required documentation.