FDA WARNING_LETTER - PLZ Corp. - September 01, 2025

On June 2, 2026, the FDA issued a warning letter to PLZ Corp regarding its manufacturing facility in Mississauga, Ontario, following a records review initiated in September 2025. The agency determined that the facility’s over-the-counter (OTC) drug products were manufactured in violation of Current Good Manufacturing Practice (CGMP) regulations, as defined under the Federal Food, Drug, and Cosmetic Act. A primary violation involved the company’s failure to adequately test raw materials, specifically talc, for identity and purity. The FDA emphasized that talc is at high risk for asbestos contamination, a known carcinogen, yet PLZ Corp failed to perform necessary testing or validate the reliability of its suppliers" results. Additionally, the company’s quality control unit failed to establish sound specifications for manufacturing and lacked sufficient oversight to ensure product safety. To resolve these issues, PLZ Corp must conduct a comprehensive risk assessment of all products containing ingredients prone to asbestos contamination and perform testing on retained samples. They are also required to implement a gap analysis of their testing procedures and provide a remediation plan to empower their quality unit. Although the company has stated it no longer manufactures talc-containing products, the FDA requires formal notification and rigorous documentation before any such production resumes. Failure to address these deficiencies may result in the FDA blocking the company’s products from entering the United States.