The US health regulator has banned products from Maharashtra-based bulk drug maker Laxachem Organics for refusing inspection of its plant.
The US Food and Drug Administration (USFDA) has placed Laxachem Organics Pvt Ltd on import alert 99-32 that allows detention without physical examination of products from firms refusing FDA foreign establishment inspection, FDA said on its website.
The alert was issued because the company refused to allow FDA investigators to inspect its facility, it added.
“The import alert stops all Laxachem pharmaceutical products from entering the United States legally,” FDA said.
Laxachem manufactures active pharmaceutical ingredient (API) for repackagers, labellers, 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,” USFDA said.
One of the drugs Laxachem manufactures is Docusate Sodium USP, the regulator said, adding it had received several adverse event reports of B cepacia infections in patients.
Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech, it said.
Under the Federal Food, Drug and Cosmetic 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, it added.