Another Pharmaceutical Company Criticized by FDA
The U.S. Food and Drug Administration has issued a warning letter to Sun Pharma’s U.S. based subsidiary Caraco in Detriot, Michigan for certain manufacturing deficiencies. The letter was issued as a follow up to the last FDA inspection of the company's manufacturing facility in Detroit initiated in May 2008. This latest suspension is on the heals of a ban imposed on 30 drugs manufactured by another pharmaceutical company, Ranbaxy in India. The FDA is directing Caraco to report what measures it will take to resolve the deficiencies. Until such a time, the FDA has suspended the approval of any drug applications until the issue is resolved. There are 96 abbreviated new drug applications (ANDAs) filed by Sun Pharma awaiting approval, of which 19 have been filed by Caraco. “The FDA has not banned the sale of Sun Pharma drugs in the US, and there was no recall of medicines by the company in the US market,” a company official stated. Sun Pharma and Caraco collaboratively market about 60 products in US. In response, company officials believe, “Any adverse happening in India and China always gets magnified adverse publicity.” Well, when hundreds of thousands of people are put at risk from lack of quality control measures, it tends to worry them. In addition to Ranbaxy, pharmaceutical companies Wockhardt and Granules India received similar warning letters from the US FDA in the past for defects at their facilities.
