Drugs

Suzhou Pharmaceutical CGMP Violations

A 6/6-6/8/16 FDA inspection at Suzhou Pharmaceutical Technology, Suzhou, China, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients (APIs), according to a 1/6 Warning Letter. Specific deviations cited in the letter include:

failing to transfer all quality or regulatory information received from the API manufacturer to customers;
failing to have a quality unit responsible for reviewing and approving all appropriate quality-related documents, including certificates of analysis; and
failing to have facilities suitable for storing all materials under appropriate conditions.

The letter notes that the firm shipped APIs in 5/2015 to the U.S. that were obtained from a manufacturer that was under an FDA import alert. The agency says it strongly recommends that the company engage a consultant qualified to evaluate its operations and assist it in meeting CGMP requirements.

Suzhou was told to submit: (1) written procedures for the transfer of quality and regulatory information to its customers, including specific details of the information it will transfer; (2) a plan to establish, document, and implement an effective system for managing quality, including written procedures for CGMP-related activities and the personnel responsible for oversight; and (3) corrective actions for establishing and maintaining adequate storage conditions.

FDA placed the company on an import alert 10/17/16. It told the firm to respond with steps taken since the inspection to correct the deviations and prevent their recurrence, along with a timetable for completion.

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