FDA WARNING_LETTER - Gopaldas Visram & Co., Ltd. - August 01, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter on June 2, 2026, to Gopaldas Visram & Co., Ltd., following a review of records requested in August 2025 regarding their manufacturing facility in Navi Mumbai, India. The document outlines significant violations of Current Good Manufacturing Practice (CGMP) regulations, leading the FDA to classify the company"s over-the-counter drug products as adulterated under the Federal Food, Drug, and Cosmetic Act. The primary concerns center on the company’s quality control oversight, particularly regarding products containing talc. Because talc carries a risk of asbestos contamination—a known carcinogen—the FDA classifies these as high-risk products. The investigation revealed that the firm’s quality unit failed to ensure that testing procedures for talc were scientifically sound or consistent with official standards. Notably, laboratory records showed suspicious data, such as identical results for different samples, and failed to properly screen for asbestos. Additionally, the company released raw materials for production that did not meet established safety and identity requirements. To address these issues, the FDA requires Gopaldas Visram & Co., Ltd. to implement a comprehensive remediation plan. This includes strengthening the authority of their quality department, conducting a thorough investigation into data inaccuracies, and performing retrospective testing on stored samples of talc and finished products to ensure they are free of asbestos. The company must also provide an update on its efforts to reformulate products to remove talc entirely. A written response detailing corrective actions is required within 15 working days, or the company faces potential import restrictions.