Less than two months before the FDA rejected Intarcia Therapeutics’ potential blockbuster treatment for type 2 diabetes last year, inspectors at the agency faulted the company for a litany of issues at its Hayward manufacturing plant and warned about potential drug contamination, an agency document shows.
The manufacturing warning letter, known as a Form 483, offers new clues about why the FDA declined to approve Boston-based Intarcia’s drug in September 2017. Since that time, the company has…
