FDA 483 - Wisconsin Pharmacal Company - March 07, 2025

Wisconsin Pharmacal Company, LLC, a non-sterile OTC drug manufacturer in Jackson, WI, was cited for significant quality control and data integrity deficiencies. The inspection revealed instances where drug products failing specifications, including microbial contamination, were released without adequate investigation or recall. Additionally, the firm lacked proper procedures for preventing objectionable microorganisms, maintaining computer system controls, ensuring robust laboratory testing, and documenting equipment use.