The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration 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 toLaxachem’sdisclaimer iconwebsite, 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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Revelation 19:16 On his robe and on his thigh he has this name written: KING OF KINGS AND LORD OF LORDS. This blog is to present Up To Date Prophetic News. My prayer is that this blog will bring others to know Jesus as their Savior if they do not know him the King of Kings and Lord of Lords.

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Posted in 2016, AMERICA, FDA, Forewarned, INTERNATIONAL, Signs of the Times, WORLDNEWS

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August 2016

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