Drugs

CGMP Issues at China’s Shandong Boyuan

An FDA review of records submitted by Shandong Boyuan Pharmaceutical Co. in Shandong, China, at the agency’s request, identified current good manufacturing practice (CGMP) deviations in the firm’s manufacturing of active pharmaceutical ingredients (APIs). A just-released 10/17 Untitled Letter says the specific deviations were:

failure to demonstrate that the firm’s manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes;
failure of the firm’s quality unit to ensure that there is stability data to support retest or expiry dates and storage conditions of APIs; and
failure to ensure that all test procedures are scientifically sound and appropriate to ensure that APIs conform to established standards of quality and purity.

The letter says FDA strongly recommends the firm retain a qualified consultant to perform a comprehensive audit of its entire operation and evaluate the completion and efficacy of its corrective and preventive actions before it pursues resolution of its compliance status with FDA.

FDA acknowledges that the company indicated its APIs were in the research and development stage, were not intended for the U.S. market, and were imported to the U.S. without the company’s knowledge. Shandong said it was attempting to identify the entity that imported the APIs.

The company subsequently informed FDA that it intends to distribute drugs to the U.S. market in the future, the letter says. The company was later informed that the APIs that were previously imported were intended for human drug compounding.

All drugs manufactured by Shandong were placed on a 7/15 Import Alert, FDA says. It says the firm’s products will remain on Import Alert until FDA verifies corrective actions and finds that the company complies with CGMP.

Shandong was told to respond with a list of specific actions it has taken to address deviations and prevent their recurrence, with a schedule for completing the corrections.

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