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09-21-2013, 02:56 AM #1
FDA inspection raises serious questions for Ranbaxy Laboratories
The presence of suspected human hair in a tablet manufactured at Ranbaxy Laboratories's Mohali plant near Chandigarh is part of a wider failure by the Indian drugmaker to adequately investigate its manufacturing problems, says the US drug regulator that issued an import alert on the plant last week.
The US Food and Drug Administration (FDA)'s import restrictions came after US inspectors found several deviations in Ranbaxy's quality control documents, including the failure to investigate the root cause of a black fibre found embedded in a tablet that may have been a hair from an employee's arm.
"In September and December 2012, FDA inspections identified significant violations of current good manufacturing practice (CGMP), including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality," a USFDA spokesperson told Business Today in an email. "There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed."
The drug regulator says the company did not analyse the black fibre or take any measures to fix the problem.
"It (the company) concluded that a black fiber embedded in a tablet was likely either a white tape remnants on the nozzle head of the machine or a hair from an employee's arm that could be exposed on loading the machine," FDA said in a list of observations sent to Ranbaxy after investigations. "It did not conduct any analysis of the fiber to support these root causes. Further, a plan to evaluate whether the corrective actions of trimming the tape and implementing longer gloves for employees were effective was not established."
In another case of discrepancy, where the company investigated and concluded that the root cause of a problem was the use of dirty glassware by an analyst, the FDA observes that "the investigation did not reveal the source of the uncleaned glassware".
Nevertheless, the US drug regulator does add that it had not received any complaints or reports that patients have been harmed from the use of products Ranbaxy manufactures at its three Indian facilities on the import alert.
Ranbaxy did not comment on the FDA's findings. But it has said it hopes the matter will be resolved soon and is willing to cooperate with any regulator that wants to investigate its manufacturing practices.
Ranbaxy has been pinning its hopes on Mohali after the FDA slapped import bans on its Paonta Sahib and Dewas plants in 2008. It was banking on three generic drugs - blood pressure pill Diovan, stomach medicine Nexium and anti-viral medicine Valcyte - which it expects to roll out of the plant in Punjab this year.
But the import alert bars Ranbaxy from supplying any products from Mohali to the United States until it has the FDA's approval, making it the company's third unit to be barred from shipping its products to the United States.
Analysts say the US import restrictions are likely to slow Ranbaxy's growth plans and hit product launches in its biggest market.
The latest FDA impact alert is the latest in a series of blows to Ranbaxy's US business. In May, it had pleaded guilty to felony charges relating to the safety of drugs made at two units in India and agreed to pay $500 million to US authorities as a penalty.