Chinese API Manufacturer is Latest to Receive Warning for Data Integrity

The FDA last month warned a Chinese active pharmaceutical ingredient (API) maker for data integrity violations, marking the agency’s 13th warning letter to cite data integrity out of 18 overall warnings released in 2014 for quality violations.

By contrast, in 2013, the agency cited data integrity problems in only seven out of 26 warning letters it issued for good manufacturing practice (GMP) violations. The figures only represent drug and API makers that received a warning letter for violating GMPs. The vast majority of the data integrity letters issued in both 2014 and 2013 were to international manufacturers.

The latest letter, released Dec. 30, warned Novacyl Wuxi Pharmaceutical for a slew of GMP and data integrity violations stemming from an October 2013 inspection of its Jiangsu, China, facility.

Investigators, for example, discovered that personnel had thrown away a chromatogram result for an API that was out of specification. The API manufacturer also didn’t use separate passwords for each analyst’s access to the laboratory systems, according to the Dec. 19 letter.

The letter is more evidence that the FDA is making good on its promise of raising data integrity to a high priority. One violation could cast doubt on the reliability of all data generated at a facility, officials have said. The FDA also has called on drugmakers to do a better job of reviewing data integrity practices of their suppliers.

The focus on data integrity in 13 of 18 GMP warning letters in 2014 stands in sharp contrast to 2013, when it was cited in only seven out of 26 GMP warning letters.

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