A March 30, 2011, Food and Drug Administration (FDA) Warning Letter to Ningbo Smart Pharmaceutical Co. revealed that it had reported conformance to specifications on certificates of analysis, when in fact no testing was done—among other issues.

The FDA rather understatedly informed Ningbo Smart, “It is essential that your firm only report results to customers when you have actually performed the analysis.”

However, FDA was quick to advise the Chinese active pharmaceutical ingredient (API) manufacturer of the full implication of its testing and reporting practices. “This serious CGMP [current good manufacturing practice] violation raises concerns regarding the reliability and integrity of other data generated by your firm.”

This was the same language used by the FDA in the Jan. 28, 2010, Warning Letter to Xian Libang Pharmaceutical Co. in Shaanxi, China, for using the infrared spectra for one lot of incoming material to support the release of subsequent material.

The term “data integrity” is not just casual language.

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