Regulatory Focus™ > News Articles > Three Asian Companies Banned From Sending Imports to the US by FDA

Three Asian Companies Banned From Sending Imports to the US by FDA

Posted 04 December 2015 | By Zachary Brennan 

Three Asian Companies Banned From Sending Imports to the US by FDA

China-based Jinan Jinda Pharmaceutical Chemistry Co., Zhejiang Qianfei Enterprise Co. and Hong Kong-based Chan Yat Hing Medicine Factory were added to the US Food and Drug Administration’s (FDA) import alert list over the last two weeks, effectively banning the companies from shipping products to the US.

FDA has now added 21 new companies to its import alert list in 2015, with companies listed from Canada (1), China (4), Czech Republic (1), Denmark (1), Hong Kong (1), India (8), Mexico (1), Thailand (2), Tunisia (1) and the United Kingdom (1).

Recent Additions

On 25 November, FDA added Jinan Jinda to its import alert list. The active pharmaceutical ingredient (API) manufacturer of more than 30 products, some intended for US and EU markets, says it was last audited by FDA and China’s FDA in April, though neither regulator nor the company has released information on that audit.

The Italian Medicines Agency, however, did issue a good manufacturing practice (GMP) non-compliance report for the company in July, identifying 18 deficiencies, including six major and one critical.

“The critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall, which during the inspection the Company was requested to remove,” the agency says. “The material stored in this area was to be managed outside of the Quality Assurance system and the investigation carried out by the inspection team concluded there was a serious risk of data falsification.”

Health Canada also has Jinan Jinda listed on its inspection tracker under its “closed” tab as the company doesn’t have any “medically necessary products identified at this time,” though a non-compliant rating was issued for data integrity and good manufacturing practice (GMP) issues.

In addition to Jinan, cosmetic manufacturer Zhejiang Qianfei was also added to the FDA import alert list on 24 November for GMP issues.

Similarly, Hong Kong-based Chan Yat Hing, which manufactures over-the-counter medicated oils (and sells a variety of medicated oils and balms on Amazon), was cited by FDA for good manufacturing practice (GMP) violations and added to the alert list on Thursday. The company previously received a Form 483 from FDA’s Center for Drug Evaluation and Research in July.

Back in 2010, the Hong Kong Department of Health also notified FDA and urged consumers not to buy or use one of Chan Yat Hing’s topical medicines called "Loong Fung Trade Mark Singapore Chi Len Chun Fung Oil" as it was found to contain aspirin.

According to the manufacturer, about 10,200 bottles of the topical medicine were manufactured in 2009, and 2,900 bottles have been exported to the US.

A representative from El Monte, California-based Lucky Mart, which previously had a contract with Chan Yat Hing three years ago, told Focus that it stopped selling the company’s products.

FDA Import Alert List

 

 


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