Drugs

CGMP Violations Found at Tai Heng Industry

A 5/4-11/15 FDA inspection at Tai Heng Industry, Shanghai, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to a 5/12 Warning Letter. Specific deviations observed included:

failing to adequately investigate out-of-specification results and implement appropriate corrective actions;
failing to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data; and
failing to record activities at the time they are performed, and destruction of new data.

The letter says the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. “We acknowledge your commitment to hire a third party to perform audits of your quality system, but believe that the proposed audit is inadequate,” it says. “We recommend more frequent reviews of your quality system for more timely oversight and compliance with CGMP. We also recommend that your third-party audit include appropriate evaluation of sophisticated electronic systems and the possibility of data integrity manipulation of such systems.

In response to the Warning Letter, Tai Heng was told to provide (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the drugs’ quality; and (3) a management strategy including details of a global corrective action and preventive action plan.

The company was told to provide reasons if it could not complete corrective activities within 15 working days.

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