FDA issues Import Alert for all drug products including api used by compounding pharmacies produced by Suchem Laboratories in India

[07/9/2015] The U.S. Food and Drug Administration placed Suchem Laboratories, Ahmedabad, Gujarat, India, on Import Alert on April 30, 2015, for refusing to allow FDA investigators to continue to conduct an inspection of its facility. The Import Alert stops all Suchem Laboratories pharmaceutical products from entering the United States.

 

Under the Federal Food, Drug and Cosmetic Act (FD&C Act), drugs made at a facility that denies, limits, or delays an FDA inspection are considered adulterated. Suchem Laboratories will remain on Import Alert until it is fully inspected by FDA and found to meet U.S. standards. 

 

Suchem Laboratories manufactures active pharmaceutical ingredients (APIs) for repackagers, labelers, and distributors some of which sell these APIs to compounding facilities in the United States. FDA contacted companies that directly received APIs from Suchem Laboratories and asked these companies to quarantine any API manufactured by Suchem and not distribute the API or products containing the API to customers. 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.