One of the issues that the FDA has uncovered at several Indian drug manufacturing plants it has inspected is a penchant for messing with drug analytics to get the data companies need for drugs to be approved. Now the FDA has sent a warning letter to yet another Indian drugmaker accusing its analytics lab of making up sample weights used to test drugs, then using the results in FDA drug applications.
The warning letter filed Tuesday is for inspections done last year at the USV lab in Mumbai. The agency says the three responses from the drugmaker have not convinced the agency that it is doing everything necessary to root out how extensive the problems were and what plants and products were potentially affected by the false data.
"The lack of reliability and accuracy of data generated by your firm is a serious CGMP deficiency that raises concern for all data generated by your firm," the letter reads. "While we acknowledge the commitment in your response that your staff is being interviewed to determine the extent of the problematic laboratory activities, we remain concerned about the capability and credibility of your quality unit."
The FDA pointed out that after problems were uncovered at the facility in 2009, USV agreed to audit its testing results going back to 2006. It said, however, those efforts did not prevent the problems the FDA uncovered last year. Among issues was the fact that analysts did not record balance weights at the time of sample weighing, instead creating them after the chromatographic runs and backdating them in notebooks. It then used those weights to determine impurities used in support of method validations submitted in FDA drug applications. The FDA wants USV to track down former employees and interrogate them about what facilities and products might have been affected by inaccurate data reporting. It also points out that the computer program that would have allowed the FDA to see an audit trail had been disabled.
Falsifying drug analytics has been a recurring theme in facility inspections the FDA has been doing in India. It factored into the early problems at Ranbaxy Laboratories for which it pleaded guilty and paid a $500 million fine last May, then surfaced again as a key problem at its Toansa API plant that the FDA banned last month. It also was a noted at the Wockhardt plants the FDA banned last year and at an Indian facility owned by Germany's Fresenius Kabi that got a 2013 warning letter.
- read the warning letter to USV
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