FDA 483 - Grand River Aseptic Manufacturing, Inc. - November 04, 2025

Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI, was inspected and cited for significant deficiencies in its aseptic process validation, specifically regarding media fills that did not represent typical worst-case conditions or routine production. Additionally, the firm lacked written procedures for its quality control unit, particularly concerning data integration optimization and analyst access privileges, raising concerns about data integrity.