Increased US FDA oversight driving recent China plant warnings

By Dan Stanton

- Last updated on GMT

Image: iStock/Evgeny Sergeev
Image: iStock/Evgeny Sergeev

Related tags Food and drug administration

The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.

Last week, the US Food and Drug Administration (FDA) published a Warning Letter​ issued to Chan Yat Hing Medicine Factory after inspectors found evidence of significant violations from current good manufacturing practice (CGMP) for finished pharmaceuticals made at the firm’s site in Hong Kong.

The Letter was the latest in a string of compliance issues surrounding drug and active pharmaceutical ingredient (API) makers in the region:

Zheijiang Hisun Pharmaceuticals was slammed with data integrity issues in December​, while in the same month potential particulate matter in batches of the API baclofen made by Taizhou Xinyou Pharmaceutical & Chemical led to the Agency issuing a safety alert​ to US compounders.

The growing number of warnings and safety alerts is due to an increase in regulatory oversight, an FDA spokesman told

“Drug inspections in China have been increasing​,” he said. “The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 required the FDA to achieve the same inspection schedule for foreign facilities as domestic manufacturers.”

FDA presence in China

The majority of the drug inspections which the FDA conducts in China focus on manufacturers of APIs intended for use in generic drugs and on sites that produce over-the-counter (OTC) drugs, we were told.

“Our presence in China allows us to better collaborate with our Chinese regulatory counterparts and enables us to leverage our combined resources, harmonize science-based standards and increase regulatory capacity.  In doing so, FDA continues to ensure that medical products moving in international commerce are safe, effective, and of high quality.”

The Agency has made a concerted effort to increase its presence in China, pushing the number of regional staff from eight to 26 by pledging extra funds to boost its regional team​, and lobbying the Chinese Government to secure visas​ for the new drug manufacturing site inspectors.

But even with this push, the team may have its work cut out as around 500 of the 3,600 plus Finished Dosage Form Facilities (FDF) and API Facilities registered under the 2013 Generic Drug User Fee Act (GDUFA)​ are located in China.

2015 Warning Letters

But while Chinese oversight has increased, the number of Warning Letters issued in the country last year pales in comparison to the number in India.

Twelve out of the 19 overseas FDA warnings issued in 2015 by the FDA’s Center for Drug Evaluation and Research (CDER) for cGMP violations were delivered to Indian facilities.

Three were issued to Chinese firms, two to Canadian sites, while facilities in New Zealand, Czech Republic and Thailand made up the total.

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