Wisconsin Pharmacal Company, LLC

Warning LetterOpen

Mr. Heath Ashenfelter President and CEO Wisconsin Pharmacal Company, LLC 1 Pharmacal Way Jackson , WI 53037 United StatesFEI 2124143Issued Aug 22, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2124143.

Violations4

Issue DateAug 22, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Wisconsin Pharmacal Company, LLC
Location: Mr. Heath Ashenfelter President and CEO Wisconsin Pharmacal Company, LLC 1 Pharmacal Way Jackson , WI 53037 United States
FEI Number: 2124143
Country: United States
Issue Date: August 22, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

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.

Wisconsin Pharmacal Company, LLC FDA Warning Letter, August 22, 2025