Loading…
Wisconsin Pharmacal Company, LLC received a warning letter for manufacturing adulterated finished pharmaceutical drugs that violated Current Good Manufacturing Practice (CGMP) regulations. The FDA found that the company's quality control unit failed to provide adequate oversight of over-the-counter drug products, including rejecting batches that failed assay tests for strength but then releasing approximately half of those rejected units for distribution anyway. The inspection conducted in March 2025 identified failures in the quality unit's responsibility to ensure drug products met established specifications for identity, strength, quality, and purity as required under 21 CFR 211.22.