FDA issues import alert for all drugs produced by Laxachem Organics in India
Decision taken after company refuses to allow FDA facility inspection.
The FDA has placed Laxachem Organics Pvt. Ltd., Ahmednagar, Maharashtra, India, on import alert (on 11 August 2016), for refusing to allow FDA investigators to inspect its facility.
The import alert stops all Laxachem pharmaceutical products from entering the US legally.
Laxachem will remain on import alert until it has been fully inspected by FDA and found to meet US 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’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.
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