Warning Letter Targets Chinese Biotech Company

The FDA warned a Chinese maker of active pharmaceutical ingredients over data integrity lapses and other serious deviations from current good manufacturing practice.

Yunnan Hande Bio-Tech lacked controls to prevent unauthorized access to and manipulation of raw electronic data, according to the April 6 warning letter. An infrared spectrometer did not include access controls, meaning anyone could delete or change the data, the letter says. During the April 14-17, 2014, inspection at the firm’s Kunming, Yunnan Province, facility, investigators also found that computer software lacked active audit trail functions to record any data alterations.

While the company said it would add full audit trail features to its infrared software, the proposed step doesn’t make clear how Yunnan Hande will ensure data integrity or maintain data before the change is implemented, the FDA says.

The FDA also chides the company for not performing infrared identity tests on all API lots and for modifying a spectrophotometer file name containing sample identification information for one lot to support the release of two previously manufactured lots.

Finally, the company failed to ensure that APIs meet specifications for quality and purity, the FDA says. For example, Yunnan Hande’s quality unit failed to detect that the laboratory altered the infrared raw data and mischaracterized the approval and release results of certain API lots, the warning letter says.

The FDA told Yunnan Hande to provide a comprehensive plan to ensure the integrity of data used to assess the quality of its APIs and a risk assessment to determine the effects of poor documentation practices on product quality. The agency also urged the firm to seek a third-party audit to ensure future compliance.

To avoid potential drug shortages, Yunnan Hande should notify the FDA if its response will result in a cut in production, the agency adds.

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