FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers

Regulatory NewsRegulatory News | 08 April 2016 |  By 

Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection.

On Wednesday, FDA added Xinxiang Pharmaceutical Co. and Xinxiang Tuoxin Biochemical Co., noting: “Only drug and drug products (i.e. adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are subject to DWPE [Detention Without Physical Examination] under this notice.”

Both companies received FDA Form 483s in 2015, as did Guangzhou Haishi Biological Technology Co., which was also added to the cGMP alert list on 14 March 2016.

There are now 44 Chinese companies on the list, which means these companies’ products are banned from entering the US. Between FY 2009 and FY 2015, FDA conducted 1,389 inspections in China, though only 468 of those were conducted by FDA's Center for Drug Evaluation and Research, and of those 468, only 23 inspection reports called on the companies to take official action, according to an FDA data dashboard.

Since 2014, FDA has issued eight warning letters to Chinese pharmaceutical and API companies, including:

The import alert list and number of inspections and warning letters grow as congressmen recently criticized FDA’s handling of its investigation into tainted Heparin from China that killed more than 100 in the US in 2007 and 2008, and which have come back into the spotlight since French regulators uncovered additional concerns with Heparin manufacturing and sourcing in a December inspection in China.

Inspection Refused

In addition to the GMP concerns, Ji’an-based Jiangxi Yuneng Pharmaceutical Co. refused an FDA inspection of its pharmaceutical manufacturing facility and was placed on import alert.

The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s inspectional personnel, combined with other evidence, provides an appearance that the firm’s products are manufactured, processed, or packed under insanitary conditions,” FDA says.

Jiangxi joins four other Chinese pharmaceutical companies on FDA’s list. According to Jiangxi’s website, the company manufactures dexamethasone sodium phosphate, Deflazacort and the steroid betamethasone.

The new import restrictions come as China is dealing with the discovery that millions of vaccine doses used there were improperly stored or outdated.

Import Alert 66-40

Import Alert 99-32


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