Drugs

API Deviations Found at Kyowa Hakko Bio

A 9/4-9/8/17 FDA inspection at Kyowa Hakko Bio Co., Yamaguchi, Japan, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to an 8/10 Warning Letter. Specific deviations cited in the letter were:

failure of the quality unit to exercise its responsibility to ensure the API manufactured at the facility comply with CGMP; and
failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to have adequate controls to prevent omission of data.

The letter notes that similar deviations were cited in an earlier Warning Letter and also were cited during a 2017 inspection at another company site. “These repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The agency says the firm’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. FDA acknowledges the firm’s use of a consultant to audit its operation and assist in meeting FDA requirements. Kyowa was told to provide (1) a comprehensive investigation into the extent of inaccuracies in data records and reporting; (2) a current risk assessment of the potential of the observed failures on the quality of the company’s drugs; and (3) a management strategy for the firm with details of its global corrective and preventive action plan.

Kyowa was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their occurrence, with a timetable for completion.

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