Data Integrity Problems Found at Indian Facility

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FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

On Nov. 8, 2016, FDA sent a warning letter to Srikem Laboratories Pvt. Ltd. detailing data integrity violations found during a December 2015 inspection of the company’s Navi Mumbai facility. Specifically, the company failed to properly document laboratory control records.

FDA stated in the letter that the company failed to include complete data from all laboratory tests. The agency wrote, “Your quality unit must review all pertinent analytical data when making batch release decisions in order to determine batch quality.”

Laboratory records were also found to be inconsistently dated. The company responded to the observation saying the discrepancies were due to software malfunctions, power outages, and personnel shift changes. In the warning letter, FDA stated, “your response is inadequate because you have not sufficiently explained how you are improving controls, notwithstanding these claimed sources of discrepancies, to ensure the reliability and accuracy of the data you rely on to evaluate the quality of your drugs.”


Because of the observed violations and the company’s response to those violations, FDA placed Srikem Laboratories Pvt. Ltd. on Import Alert 66-40 on July 6, 2016. The agency recommended the company perform a comprehensive investigation into the data inaccuracies, conduct a risk assessment of potential effects of the data integrity failures on product quality, and develop a management strategy that includes a corrective action and preventive action plan.

Source: FDA