FDA 483 - L. Perrigo Company - March 19, 2025

L. Perrigo Company in Allegan, MI, was inspected and cited for multiple significant deficiencies related to data integrity, quality control, and facility maintenance. The inspection revealed issues with computer system controls, the drug product stability program, labeling and packaging material procedures, equipment cleaning validation, and adherence to sanitation protocols. These observations indicate a need for improved procedural adherence and robust quality system implementation.