FDA 483 - Grand River Aseptic Manufacturing, Inc. - July 02, 2021

An FDA inspection of Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI, revealed multiple deficiencies across its quality, production, laboratory, materials, and facilities systems. Key issues included inadequate investigations into out-of-specification results, failure to adhere to standard operating procedures for visual inspection kits and balance operations, and a lack of appropriate specifications for drug products. The firm also failed to follow procedures for material handling and expiration, maintained deficient aseptic processing areas, and had buildings and equipment in disrepair.