CGMP Violations at Japan’s Daito Kasei Kogyo

A 7/18-7/21/17 FDA inspection at Daito Kasei Kogyo, Okayama, Japan, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API), according to a 1/18 Warning Letter. Specific deviations were:

•          failing to ensure that appropriate laboratory tests are conducted for each batch of API to determine conformance to specifications; and
•          failing to completely report test results on certificates of analysis.

FDA recommends that the firm contract with a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The letter also 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. The company was placed on an import alert 10/25/17.

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