FDA 483 - Grand River Aseptic Manufacturing, Inc. - September 19, 2024

Grand River Aseptic Manufacturing Inc. in Grand Rapids, MI, was inspected by the FDA from September 16-19, 2024. The inspection revealed issues related to manufacturing process validation and documentation practices. Specifically, a syringe filling line validation study did not simulate all necessary steps, and unplanned activities were not timely documented in batch records.