The US Food and Drug Administration has placed Laxachem Organics Pvt. Ltd., Ahmednagar, Maharashtra, India, on import alert 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 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.
Companies that received API from Laxachem should not distribute the API or products containing the API to customers, said the USFDA order. 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.
