The U.S. Food and Drug Administration (FDA) placed Laxachem Organics Pvt. Ltd., Ahmednagar, Maharashtra, India, on import alert on August 11, 2016, for refusing to allow FDA investigators to inspect its facility. The import alert stops all Laxachem pharmaceutical products from entering the United States legally.
Laxachem will remain on import alert until it has been fully inspected by FDA and found to meet U.S. standards.
Laxachem manufactures active pharmaceutical ingredient (API) for repackagers, labelers, and wholesale drug distributors, some of which sell API to manufacturing facilities in the United States. According to Laxachem’s website, one of the drugs Laxachem manufactures is Docusate Sodium USP.
Companies that received API from Laxachem should not distribute the API or products containing the API to customers.
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), drugs, including APIs, made at a facility that denies, limits, or delays an FDA inspection are considered adulterated. The FD&C Act prohibits distribution of adulterated products.
For more information, see FDA guidance for industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.
For more information on this update, please visit: Laxachem Organics.
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