FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers

Three other Chinese pharmaceutical companies have added two Food and Drug Administration (FDA) lists import alert this week for failing to comply with good manufacturing practice (GMP) standards FDA to reject the FDA inspection.

On Wednesday, the FDA added Xinxiang and Xinxiang Pharmaceutical Co. Tuoxin Biochemical Co., stating: "Only pharmaceuticals and medicines (ie, adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are subject to DWPE [Detention Without physical examination] under this notice ".

The two companies have received FDA Form 483s in 2015, as Guangzhou Haishi Biotechnology Co., which has also been added to the alert list cGMP 14 March 2016.

Currently there are 44 Chinese companies on the list, which means that the products of these companies are prohibited from entering the United States. Between FY 2009 and FY 2015, the FDA conducted 1,389 inspections in China, but only 468 of which were conducted by the FDA Center for Drug Evaluation and Research Drug, and of those 468, only 23 inspection reports have called on companies to take formal action, according to the FDA panel data control.

Since 2014, the FDA issued warning letters to eight API and Chinese pharmaceutical companies, including: - More: http://www.raps.org/Regulatory-Focus/News/2016/04/08/24728/FDA-Continues-Crackdown-on-Noncompliant-Chinese-Pharmaceutical-Manufacturers/#sthash.x62qw5GP.dpuf

• Beijing Shunxin Co. Meihua Bio-technology
• China Resources Sanjiu Medical and Pharmaceutical Co
• Novacyl Wuxi Pharmaceutical Co. Ltd.
• Zhejiang Jiuzhou Pharmaceutical Co.
• Tianjin Zhongan Pharmaceutical Co., Ltd.
• Yunnan Hande Bio-Tech. Co. Ltd.
• Wuxi Kaili Pharmaceuticals Co., Ltd.
• Zhejiang Hisun Pharmaceutical Co.

The list of import alert and the number of inspections and warning letters grow as members of Congress recently criticized the handling of the FDA investigation of contaminated heparin from China that killed more than 100 in the United States 2007 and 2008, and back into the spotlight as the other French regulators discovered with the manufacture and supply of heparin in December inspection in china problems.

The Refusal of Inspection

In addition to the GMP concerns Yuneng based Ji'an Jiangxi Pharmaceutical Co. declined an FDA inspection of its facilities and pharmaceutical manufacturing was placed on alert for import.

"The refusal to allow inspection of a foreign operation, or provide reasonable access to staff FDA inspection, combined with other evidence, provides an aspect that the company's products are manufactured, processed or packaged in unsanitary conditions, "says the FDA.

Jiangxi joins other four Chinese pharmaceutical companies in the list of the FDA. According to the website of Jiangxi, the company manufactures dexamethasone sodium phosphate, betamethasone, deflazacort and steroids.

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