Macsen Drugs – FDA Warning Letter, Sep 6, 2024

The FDA issued a warning letter to Macsen Drugs, located in Udaipur, Rajasthan, India, following an inspection from September 2 to 6, 2024. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) standards for active pharmaceutical ingredients (APIs). These deviations result in the APIs being considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include the failure of the quality unit to ensure compliance with CGMP, particularly after a significant fire on December 5, 2022, which affected storage conditions. Despite the fire"s impact, the quality unit released compromised API lots for distribution in the U.S. market. Additionally, the facility lacks stability data to support retest or expiry dates and storage conditions, exacerbated by frequent power failures in stability chambers without adequate monitoring systems.

The FDA requires Macsen Drugs to provide a comprehensive response within 15 working days, detailing corrective actions taken to address these issues and prevent recurrence. The company must also submit additional information if corrective actions cannot be completed within the specified timeframe. The FDA may withhold approval of new applications or supplements until compliance is confirmed and may conduct re-inspections to verify corrective actions. Macsen Drugs is encouraged to engage in a Post-Warning Letter Meeting for feedback on their corrective action plans under the GDUFA III Commitment Letter.