GURGAON, India — The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.
Ranbaxy said it received a Form 483 from the FDA, a statement issued to a company's management after it has inspected a plant and found conditions that may violate the agency's regulations, and that products produced therein could be hazardous to people who use them. The plant in question is in Toansa, in India's Punjab region.
"Ranbaxy continues to improve its systems and processes and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company," a statement from the drug maker read. "Ranbaxy stays firmly committed to its philosophy of 'Quality and Patients First.'"
In September, the FDA barred importation of drugs from the company's plant in Mohali, also in Punjab, through an import alert, meaning customs officials can seize drugs from the plant when they reach the U.S. border. The agency said the alert would remain in effect until Ranbaxy complied with the FDA's current good manufacturing practices, or CGMP. Two other Ranbaxy plans in India, Paonta Sahib and Dewas, have been under import alerts since 2008.