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    Updated: UK Company Banned From Shipping Medical Devices to US

    [ Editor's note from 2/25/16: This article has been updated with comment from Bedfont. ] The US Food and Drug Administration (FDA) has added UK-based Bedfont Scientific to its import alert list for medical device companies that have not met device quality system requirements. Bedfont is now banned from shipping its products to the US, which includes its breath test monitors, nitric oxide and carbon monoxide monitors, and medical pipeline testing equipment. “Foreign ...
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    FDA Allows Banned Chinese Firm to Ship Chemotherapy to US as Shortage Threat Looms

    [Editor's note on 2/19/16: FDA spokesman Stephen King has since offered additional comment though he could not confirm whether or not this comment applies to Zhejiang Hisun or what the company has done to ensure that the API it's allowed to send to the US is not manufactured in the same way as the APIs that are banned from entering the US .  "When FDA exempts certain drugs from an import alert due to shortage concerns, the agency also often requests the manufacturer to ...
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    CDRH Bans Imports From Australian Company for Failing to Meet Quality System Requirements

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) added Australia’s TFS Manufacturing to a list of medical device manufacturers that have not met device quality system requirements. TFS says it manufactures a tissue fixation system that “repairs organ prolapse by tensioning the ligaments and bringing laterally displaced connective tissue structures, such as ligaments and fascia, together. It combines soft tissue anchors with ...
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    Updated Again: FDA to Pull Singapore Device Firm From Import Alert List

    A subsidiary of Biosensors International, a group of companies developing, manufacturing and marketing medical devices for cardiology and critical care procedures, failed to respond to an inspection request from the US Food and Drug Administration (FDA) and its products were banned from entering the US. However, five days after the company's name was posted on the import alert list, a Biosensors spokesman told  Focus  that the company will be removed from the list aft...
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    Importers of FDA-Regulated Products Prepare for February Shift to Automated System

    In partnership with Customs and Border Protection (CBP) and 46 other government agencies, the Food and Drug Administration (FDA) has developed and is quickly transitioning to a new portal through which industry can electronically submit all data required by government agencies for international trade. As of 28 February, 2016, all importers and brokers of FDA-regulated products will have to submit entry data through the new Automated Commercial Environment (ACE). And by t...
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    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), In...
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    FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company

    The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US. CMI manufactures cosmeceuticals, nutraceuticals and pharmaceuticals, including a digestive enzyme therapy, according to its website . The company says it has a Drug Establishment License and owns the rights to many Drug Identification Number products under the CMI name. The updated FDA import alert...
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    FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems

    US medicines regulators have quietly banned drugs manufactured at a facility owned by Ipca Laboratories, an Indian pharmaceutical manufacturer, from entering into the US after finding that its products were not manufactured to federal standards. On Thursday, 22 January 2015 the US Food and Drug Administration (FDA) issued an update to its Import Alert 66-40, which is used to warn US customs officials that a company's products have not met good manufacturing practices (GM...
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    FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections

    The US Food and Drug Administration (FDA) has put the finishing touches on a new policy intended to ensure the companies it regulates aren't able to hide problems from it during the course of inspections. Background In July 2013, FDA released a draft guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection seeking to clarify its newfound authority under the Food and Drug Administration Safety and Innovation Act (FD...
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    Chinese Company Used Suppliers Linked to Contaminated Heparin Scandal, FDA Claims

    A Chinese-based manufacturer of heparin products has been sent a Warning Letter by the US Food and Drug Administration (FDA) after regulators accused the company of preventing FDA inspectors from accessing the facility earlier this year, and possibly manufacturing contaminated products. Background In its 29 September 2014 Warning Letter to Beijing Shunxin Meihua Bio-technical Co., Ltd, FDA said its inspectors were unable to access the majority of the company's Beijing...
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    FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected

    The US Food and Drug Administration (FDA) has placed a Chinese pharmaceutical manufacturer on an import alert, banning the company's products from entering the country after it allegedly refused to allow access to FDA investigators. The company, Beijing Shunxin Meihua Bio-technical Co., was placed on import alert by FDA on 22 July 2014. FDA's import alerts—one for refusing inspection , and the other for failing to operate according to good manufacturing practi...
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    Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

    • 10 July 2014
    Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US. Background The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States , is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under the ...