Wisconsin Pharmacal Company – FDA Warning Letter, Mar 7, 2025

**FDA Warning Letter Summary: Wisconsin Pharmacal Company, LLC**

**Inspection Details:** - **Company:** Wisconsin Pharmacal Company, LLC - **Location:** N168 W 22223 Main St., Jackson, WI - **Inspection Dates:** March 3-7, 2025

**Main Violations/Issues:** 1. **Quality Control Failures:** The company"s quality control unit did not adequately oversee the manufacturing and release of over-the-counter (OTC) drug products, leading to the distribution of products that did not meet established specifications for identity, strength, quality, and purity. Specifically, the firm released drug products from vessels that failed assay test specifications, indicating inadequate manufacturing and release procedures.

2. **Inadequate Investigation of Contamination:** The company failed to thoroughly investigate microbial contamination, including the presence of Staphylococcus aureus, in its OTC drug products. The firm relied on retest results without conducting a comprehensive investigation into the root cause of contamination, which is critical to ensuring product quality.

**Regulatory Framework:** - **CGMP Regulations:** Violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals as outlined in Title 21 Code of Federal Regulations (CFR), parts 210 and 211. - **FD&C Act:** Drug products are considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

**Required Actions:** - **Quality Unit Remediation:** Provide a comprehensive assessment and remediation plan to ensure the quality unit has the authority and resources to function effectively. This includes reviewing all procedures, conducting a retrospective review of testing results, and ensuring comprehensive oversight throughout operations. - **Investigation System Overhaul:** Conduct an independent assessment of the system for investigating deviations and contamination. Develop a detailed action plan to improve investigation competencies, root cause evaluation, and quality assurance oversight