FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters

Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular.

A warning letter sent at the end of May to RPG Life Sciences, headquartered in Mumbai, was followed by letters in July to Germany-based Fresenius Kabi, regarding its facility in Kalyani, and to Wockhardt, regarding its headquarter plant in Aurangabad, that together encompass an array of issues around the integrity of records, procedures and interactions with FDA investigators.

The three warning letters, in turn, follow in the wake of the high-profile revelations from FDA’s investigation of the integrity problems at Ranbaxy plants in India, which resulted in a major consent decree in January 2012 (IPQ, January 30, 2012) and have continued to garner media attention as more information from a company whistleblower has surfaced. The concerns at Ranbaxy extended into its US marketing applications, with significant consequences on its product portfolio in the US.

Two other India-based manufacturers, Aurobindo Pharma and Cadila Healthcare, received warning letters in mid-2011 that focused on the integrity of environmental monitoring and microbiology lab data, respectively (IPQ, June 13, 2011).

The recent warning letters to the three Indian firms are the only ones issued by FDA so far this year that have specifically made reference to “data integrity” as a concern. Data integrity was highlighted by FDA in several other warning letters issued in 2011 and 2012 to companies in China (ibid.), Mexico (IPQ, May 1, 2012), the United Arab Emirates (UAE) (ibid.), Canada (January 3, 2012) and the US (March 27, 2012 & June 16, 2011).

The uptick in the number of data integrity problems that FDA has been finding at manufacturing and testing facilities has prompted the drug compliance office to better define the forms in which the integrity problems can appear and the red flags that will trigger more intensive investigations (IPQ, May 16, 2012).

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