FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors

Posted 26 September 2017 By Michael Mezher

placeholder+image

The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May.

According to FDA, the firm's management admitted to falsifying analytical test results used to release a lot of its products to the US.

In another instance, FDA says the firm reported that a batch of one of its products was within specification in its certificate of analysis (CoA), even though the lab analysis showed the product to be sub-potent.

"When questioned about why the CoA reported passing results even though the batch actually failed, your quality unit manager stated, 'I made a mistake,'" FDA writes.

FDA also says its investigator witnessed "rusted and corroded screws, [redacted] fluid and debris, and metallic mesh material on the product contact surfaces," within the facility.

And, FDA says the company blocked its investigator from entering a room identified as a laboratory. When the company eventually allowed the investigator access, the investigator found the room contained no equipment.

FDA says the company then told the investigator that the laboratory was actually offsite, but that it could not give the investigator access "as it was not a convenient time."

As a result of the inspection, FDA placed Shandong Vianor on import alert in August.

FDA

Share this article:

Categories: Drugs, Compliance, Manufacturing, News, US, China, FDA

Tags: Good Manufacturing Practice, GMP, Warning Letter

Regulatory Exchange: Latest Updates From the Community