FDA inspectors discovered significant violations of current good manufacturing practice at Sun Pharma’s US plant in Cranbury, New Jersey, US during visits from February to April 2010. The company's proposed fixes, including drug recall, submitted to the agency in May, were not “sufficient corrective actions”, the FDA said in its warning letter.

It is the second time in recent months that Sun has been in trouble with the FDA due to its US business. Last June, US marshals raided three Michigan facilities operated by Caraco Laboratories, seizing drugs and stopping production. Again drug recalls were required due to manufacturing defects, including oversized tablets and formulation errors.

Sun Pharma is not the only Indian generics’ manufacturer to be facing such troubles. India’s largest pharmaceutical manufacturer (Ranbaxy) has been cited several times in recent years for manufacturing violations.

Sun Pharma has 15 days to respond to the FDA and says it is already working to correct the Cranbury problems and that it is committed to working with FDA to resolve the matter.

Until Sun Pharma comes back to the FDA with clarifications and explanations to their satisfaction, the FDA may withhold approval of pending new drug applications where the Cranbury facility was used to produce the drugs.

There have been 26 warning letters issued by the FDA in August 2010, only four of which were related to manufacturing issues by pharmaceutical companies, of which only one was a generic company.

(see also Drug recalls and generic medicines)

References:

Sun Press Release. Sun Pharma subsidiary receives warning letter from US FDA. 31 August 2010

FDA. Inspections, Compliance, Enforcement, and Criminal Investigations. Warning Letters. Sun Pharmaceutical Industries Inc. 25 August 2010

FDA News Release. U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. FDA acts to prevent repeated drug quality problems. 25 June 2010