US ban for Changzhou Jintan Qianyao raises questions about customers says expert

By Gareth Macdonald contact

- Last updated on GMT

Consultant Anders Fuglsang: "Which pharma company would ever subcontract a partner without a QMS?" (iStock/Duncan_Andison)
Consultant Anders Fuglsang: "Which pharma company would ever subcontract a partner without a QMS?" (iStock/Duncan_Andison)

Related tags: Food and drug administration, Pharmacology

The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

The US Food and Drug Administration (FDA) detailed criticisms of the firm’s plant in Changzhou, China in a recent warning letter​.

You told our investigator that you had no written procedures for testing and sampling incoming materials. Instead, you explained, your warehouse employees accounted for incoming raw material handling, sampling, and testing in their heads​.”

The agency also said it found no evidence Jintan Qianyao had any quality procedures whatsoever before August 2016.

In addition, the FDA said that none of the measures outlined in draft quality documents which inspectors were shown during a site visit in February had been implemented.

What product quality data the firm did record were incomplete and, according to the FDA, only used for the purposes of completing certificate of analysis (CoA) and batch release.

The FDA placed Jintan Qianyao on Import Alert and advised it to hire a consultant to help bring the facility up to code.

Customer responsibility

Dr Anders Fuglsang, founder of consulting firm, Fuglsang Pharma said Jintan Qianyao is part of a wider problem, suggesting US an EU pharmaceutical companies that buy ingredients from non-compliant suppliers need to take responsibility.

"Which pharmaceutical company would ever subcontract a partner without a QMS?  I think the root cause here isn't just to do with something in China. We have a big problem in the EU ad US when things like this happen​.”

Fuglsang added that: “Vendor oversight and due diligence completely neglected even though it is always the MA holders that have ultimate responsibility​."

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