Regulatory Focus™ > News Articles > FDA Warning Letter to Chinese Company Cites Supply Chain Integrity Concerns

FDA Warning Letter to Chinese Company Cites Supply Chain Integrity Concerns

Posted 30 July 2014 | By Alexander Gaffney, RAC

FDA Warning Letter to Chinese Company Cites Supply Chain Integrity Concerns

A new Warning Letter issued by the US Food and Drug Administration (FDA) this week to a Chinese pharmaceutical company accuses it of falling afoul of labeling regulations after it allegedly claimed to manufacture products that it did not.

FDA's 29 July 2014 Warning Letter cites the October 2013 inspection of Zhejiang, China-based API manufacturer Zhejiang Jiuzhou Pharmaceutical  and its shipping subsidiary, Zhejiang Zonebanner Jiuzhou Imp. & Exp. Co (Zonebanner).

The problem, FDA contended, is that the companies were found to have been relabeling products purchased or obtained from an outside manufacturer. In the case of one gabapentin-based product, the company relabeled the drug to indicate that it had manufactured the drug, when in fact another company had manufactured it.

The company also allegedly transferred information from the original COAs onto new COAs "with no information about the original manufacturer or analytical laboratory performing the analyses."

"In doing so, your firm essentially obscured the supply chain of these APIs," FDA wrote.

Other alleged deficiencies included failure to document manufacturing operations, failure to maintain control over uninspected lots, and "manufacturing equipment in need of repair."

One Company, or Two?

FDA's letter also details ZoneBanner's attempts to avoid the Warning Letter by advancing an interesting argument. The company, Zonabanner said, is a "separate legal entity under Chinese law, and is therefore not subject to many of the regulations (such as quality system controls) that its pharmaceutical manufacturing counterpart is subject to.

But in FDA's letter, the regulator said it isn't buying that argument. For starters, the companies share the same CEO, an interconnected management structure and, critically, the same physical address and office space. The companies were also described in drug shipments as being in the same "group," FDA said.

"Despite this close relationship, however, your management has allowed the Zonebanner group to continue to operate outside of your firm’s quality system," FDA wrote. Accordingly, the company needs to implement a quality system for relabeling products, FDA wrote.

The companies were put on import alert by FDA in March 2014, preventing their products from entering the US.


FDA Warning Letter


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