Grand River Aseptic Manufacturing, Inc. – FDA 483, Jun 5, 2026

Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI, a pharmaceutical drug manufacturer, was cited for three observations during an FDA inspection. The issues include failures in investigating unexplained discrepancies in batch records, inadequate routine inspection and maintenance of equipment leading to recurring issues, and non-adherence to aseptic procedures during sterile drug product manufacturing. These findings indicate significant concerns regarding quality control, equipment reliability, and contamination prevention practices.