FDA 483 - La Crosse Milling Co. - November 22, 2024

During an FDA inspection conducted from November 18-22, 2024, La Crosse Milling Co., an Active Pharmaceutical Ingredient (API) manufacturer in Cochrane, WI, received a Form 483 detailing several significant observations regarding its compliance with current Good Manufacturing Practices. A recurring issue was the absence of written and fully followed responsibilities for the Quality Unit, covering critical areas like raw material release and label control. The company's retrospective process validation was found inadequate, failing to identify or monitor critical process parameters and quality attributes such as particle and granulation size. Furthermore, the cleaning validation lacked a comprehensive protocol, specific residue testing, and documented equipment hold times. Significant deficiencies were also noted in label control and reconciliation procedures, including unaccounted for labels, insufficient documentation for destroying excess labels, and uncontrolled label printing leading to multiple expiration dates. Finally, batch production records for Colloidal Oat Flour products were incomplete, missing details on yield determinations and major equipment used. La Crosse Milling Co. is expected to implement comprehensive corrective actions to address these observations and ensure full adherence to regulatory standards for API manufacturing.