FDA 483 - Grand River Aseptic Manufacturing Inc. - September 29, 2023

Grand River Aseptic Manufacturing in Caledonia, MI, was cited for failing to establish adequate control procedures for monitoring manufacturing processes. The inspection revealed significant deficiencies in the visual inspection training and qualification for PSMA-11 vials, including the use of insufficient virtual kits and non-representative inspection setups. Additionally, the firm lacked a scientifically sound rationale for setting initial visual inspection defect reject limits and for the required number of batches before updating these limits.