Laxachem Organics of Ahmednagar, Maharashtra, India has been placed on “important alert” by the U.S. Food and Drug Administration (FDA), legally stopping all of the company’s pharmaceutical products from entering the United States. According to an update posted on the FDA website Aug. 15, the important alert was placed on August 11, 2016 because the company refused to allow FDA investigators to inspect the facility. The important alert status will remain until the FDA can fully inspect the facility and determine that it meets U.S. standards.
According to the FDA notice, Laxachem produces active pharmaceutical ingredient (API) for repackagers, labelers and whole sale drug distributors. In some cases, these products are then sold to manufacturing facilities to the United States. Docusate Sodium USP is among the drug products manufactured by Laxachem.
The FDA urges companies who received Laxachem APIs not to distribute them.
The Federal Food, Drug and Cosmetic Act (FD&C Act) prohibits adulterated products from being distributed. Under this law, products are considered adulterated if a facility denies, limits or delays an FDA inspection.
The FDA conducts inspections of foreign facilities producing FDA-regulated products to be sold in the United States. The agency may schedule an inspection ahead of time, but is not required to. The agency says in its Import Alert page, “Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin. The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions.”