FDA shuts down Detroit-area drug manufacturer Caraco Pharmaceuticals
Bloomberg.com reported on June 25 that U.S. authorities seized generic drugs produced by Caraco Pharmaceutical Laboratories, Ltd., citing multiple violations of manufacturing standards. Inspectors found "serious violations" of manufacturing standards and "serious deficiencies" in quality control when they inspected the facility in May of 2009.
The Food and Drug Administration had issued a warning letter in October of 2008 after inspections in May and June of 2008 found numerous deficiencies including cross-contamination of drugs. In April, Caraco voluntarily issued a recall on some products, but the May inspection found numerous unresolved violations. Caraco manufactures and markets 67 generic drugs. Sun Pharmaceutical Industries Ltd, an India-based corporation, owns 76 percent of Caraco.