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

An FDA inspection of Grand River Aseptic Manufacturing Inc. in Caledonia, MI, revealed significant deficiencies in manufacturing process control and quality unit procedures. Observations included a lack of statistically justified sample sizes for inspection methods and inadequate risk assessments for particulate matter. Additionally, the firm failed to properly document data processing optimization and assess the appropriateness of analyst privileges within their data systems.