Search Results for Import Alert

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Third Party Certification for Drugs Associated With an Import Alert Exception By Allyn R. Becker, PhD, Mark Lookabaugh - Published 24 November 2017

The US Food and Drug Administration (FDA) has begun a widely recognized campaign of intensified surveillance of foreign manufacturers of Active Pharmaceutical Ingredients (APIs) and finished drug products. Failure to comply with the regulatory requirements for good manufacturing practice can subject a foreign firm to an import alert, thereby cutting off access to commercial distribution in the US. This article provides an overview of the consequences of an import alert and the steps that may be required to have an alert lifted by FDA.

Categories: Features, US, FDA, Active pharmaceutical ingredients, Distribution, Drugs, Manufacturing

Tags: Third Party Certification, Import Alert

FDA Bans Imports of Piston Syringes From Nipro’s Thailand Site By Zachary Brennan - Published 25 January 2017

The US Food and Drug Administration (FDA) on Tuesday added Nipro’s Thailand site to a list of companies barred from shipping supplies of medical devices to the US because of a lack of quality.

Categories: News, Asia, US, FDA, Crisis management, Medical Devices, Quality

Tags: Nipro, piston syringes, FDA import alert

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Categories: News, China, Japan, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing, Quality

Tags: Warning Letter, Data Integrity, Import Alert

FDA Continues Crackdown on Chinese Drug Manufacturers With new Warning for Xiamen By Michael Mezher - Published 02 August 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs).

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Drugs, Manufacturing

Tags: Xiamen Origin Biotech, Warning Letter, GMP, Import Alert

Generic Drugs From Four Indian and Chinese Companies Blocked From Entering US By Zachary Brennan - Published 13 July 2016

The US Food and Drug Administration (FDA) on Wednesday added four Chinese and Indian companies to a list of generic drug facilities that are banned from shipping products to the US because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee Amendments of 2012 (GDUFA).

Categories: News, Asia, US, FDA, Compliance, Generic drugs, Manufacturing

Tags: import alert, generic drugs, GDUFA facility fees

Updated: UK Company Banned From Shipping Medical Devices to US By Zachary Brennan - Published 25 February 2016

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.

Categories: News, US, CDER, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Quality

Tags: import alert, Bedfont Scientific, device quality

FDA Allows Banned Chinese Firm to Ship Chemotherapy to US as Shortage Threat Looms By Zachary Brennan - Published 18 February 2016

The US Food and Drug Administration (FDA) on Thursday said it will allow the import of a chemotherapy’s active pharmaceutical ingredient (API) from China’s Zhejiang Hisun Pharmaceutical Co. because of concerns of a shortage.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Government affairs, Manufacturing, Quality

Tags: chemotherapy shortage, import alert, Daunorubicin HCl

CDRH Bans Imports From Australian Company for Failing to Meet Quality System Requirements By Zachary Brennan - Published 26 January 2016

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.

Categories: News, US, CDRH, Due Diligence, Medical Devices, Quality

Tags: import alert, device quality, quality system compliance

Updated Again: FDA to Pull Singapore Device Firm From Import Alert List By Zachary Brennan - Published 20 January 2016

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 an import alert list, a Biosensors spokesman told Focus that the company will be removed from the list after discussions with FDA.

Categories: News, Asia, US, FDA, Compliance, Manufacturing, Medical Devices, Quality

Tags: Singapore medical device, FDA inspections, Red List, import alert list

Importers of FDA-Regulated Products Prepare for February Shift to Automated System By Zachary Brennan - Published 09 December 2015

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.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, FDA, Active pharmaceutical ingredients, Audit, Biologics and biotechnology, Combination products, Distribution, Drugs, Government affairs, Medical Devices, Orphan products, Quality

Tags: FDA imports, import alert, ACE, CBP

Three Asian Companies Banned From Sending Imports to the US by FDA By Zachary Brennan - Published 04 December 2015

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.

Categories: Active pharmaceutical ingredients, Compliance, Cosmetics, Crisis management, Distribution, Drugs, Government affairs, Manufacturing, Nutritional and dietary supplements, Postmarket surveillance

Tags: import alert, China pharmaceutical manufacturing, pharmaceutical distribution, China imports

FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company By Zachary Brennan - Published 29 September 2015

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.

Categories: News, Canada, US, FDA, Cosmetics, Drugs, Nutritional and dietary supplements, Quality, Regulatory intelligence, Regulatory strategy

Tags: Cosmetic Manufacturers Inc., Canada pharmaceuticals, FDA import alerts, import alert list

FDA Bans Drugs Made by Indian Manufacturer Over GMP Problems By Alexander Gaffney, RAC - Published 23 January 2015

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.

Categories: News, India, US, CDER, Audit, Distribution, Drugs, Manufacturing

Tags: Ipca Pharmaceutical, GMP, Good Manufacture Practices, Import Alert, Import Alert 66-40

FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections By Alexander Gaffney, RAC - Published 21 October 2014

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.

Categories: News, US, CDER, Audit, Biologics and biotechnology, Drugs, Ethics

Tags: Guidance, Final Guidance, Inspection, Delayed Inspection, Denied Inspection, Adulterated, Import Alert, FDA Photography

Chinese Company Used Suppliers Linked to Contaminated Heparin Scandal, FDA Claims By Alexander Gaffney, RAC - Published 14 October 2014

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.

Categories: News, China, US, FDA, Biologics and biotechnology, Compliance, Ethics, Manufacturing, Quality

Tags: Heparin, Import Alert, Warning Letter

FDA Flexes New Inspection Authority, Banning Company After it Refuses to be Inspected By Alexander Gaffney, RAC - Published 24 July 2014

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.

Categories: News, China, US, CDER, Active pharmaceutical ingredients, Audit, Compliance, Drugs

Tags: Import Alert, FDASIA, FDASIA Section 709, Delayed Inspection, Denied Inspection, Limited Inspection, Import Alert