Comfort Gloves

May 28 2020FDA import alert On 26 May several types of Comfort Glove's (Comfort) examination gloves were placed under Level 2 detention We understand that this is categorised under the FDA's Import Alert 80-04 "Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves" This is the second detention for

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US FDA import alert and warning for Indian API maker

May 17 2018The US Food and Drug Administration (FDA) issued the warning letter following an inspection at Reine Lifescience's manufacturing facility in Gujurat India The active pharmaceutical ingredient (API) maker has been on US Import Alert 66-40 since March Good manufacturing practice (GMP) violations cited include failing to provide analytical method documentation and inadequate data

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The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase of the uncertified Covid-19 test kit: "DeepBlue Covid-19 (SARS-CoV-2) Antibody Test Kit" The FDA verified through post-marketing surveillance conducted on 14 May 2020 that the above mentioned medical device is not certified and/or no Special Certification has been

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Services

Stakeholder Import Alert: Change to VS policy for the Importation of Human and Veterinary Pharmacueticals approved by the Food and Drug Administration (FDA) Issuance Date: November 17 2016 Effective Date: November 18 2016 The U S Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Veterinary

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FDA Issues Import Alert For Cucumbers

4/26/2013FDA has issued an import alert for imported cucumbers supplied by Daniel Cardenas Izbal and Miracle Greenhouse of Culiacn Mexico and distributed by Tricar Sales Inc of Rio Rico AZ The import alert is in relation to the CDC's investigation of an outbreak of Salmonella Saintpaul linked to the imported cucumbers from Daniel Cardenas

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US FDA import alert and warning for Indian API maker

May 17 2018The US Food and Drug Administration (FDA) issued the warning letter following an inspection at Reine Lifescience's manufacturing facility in Gujurat India The active pharmaceutical ingredient (API) maker has been on US Import Alert 66-40 since March Good manufacturing practice (GMP) violations cited include failing to provide analytical method documentation and inadequate data

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WHO response to the USFDA import alert issued for

On 8 th March 2017 Qinhuangdao Zizhu Pharmaceutical was placed on the import alert by the USFDA The Good Manufacturing Practice (GMP) inspection was carried out by the USFDA at Qinhuangdao Zizhu Pharmaceutical No 10 Longhai Avenue Economic Development Zone Qinhuangdao Hebei China 066004 on 28 November to 1 December 2016

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FDA Import Alert – HMP Group

Import Alert 99-05 Detention without Physical Examination (DWPE) Applicable for all raw agricultural commodities FDA has the authority to place any container in detention when it arrives to the USA if there is a reason to believe that the product has chemical residuals that exceed the allowed limits in

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Import Alerts and Delays

Cosmetic Manufacturer: Negotiated with FDA a prioritized import inspection program and then removal from Import Alert 66-41 (products appearing to be unapproved new drugs) Spice Manufacturer: Persuaded FDA that an import alert did not apply and thereby avoided automatic detention for dozens of

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Warning Letter / Import Alert / Detention

Companies are placed on the Import Alert list when the company's products are subject to detention without physical examination This typically occurs when there is a history of violations the U S FDA's determines that there are health risks imposed by your company's products or potentially because of a history of violations in the country

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FDA Lawyers

FDA Lawyers Food Labeling Compliance Customs Import Alerts Food C Humphrey Associates P A is a FDA Law Firm that represents domestic and international companies regarding a range of regulatory food law issues before federal and state agencies and courts involving the U S Food Drug Administration (FDA) Federal Trade

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FDA Issues Import Alert on Cantaloupes From Mexico

Today's import alert expands the prior import alerts that targeted specific shippers and growers whose products were linked to outbreaks or tested positive for Salmonella The FDA also announced today that it will continue to work with the Mexican government on a food safety program for production packing and shipping of fresh cantaloupes

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Q and A: FDA's Deactivation of an Import Alert for

Mar 11 2019With the deactivation of the Import Alert AquaBounty Technologies is now able to sell food derived from its GE salmon in the U S and it may now import its GE salmon eggs to raise in an FDA approved U S facility The only FDA

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U S FDA Removes Many Chinese Candies From Import Alert 99

May 07 2010FDA quietly updated Import Alert 99-30 removing all FDA Product Codes in Industry 33 – or Candy Products without Chocolate – from the alert altogether FDA had already intimated this change in response to various FDAImports LLC's challenges that FDA was developing mechanisms to better target information and make informed entry

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Cellectar Announces FDA Grants Exemption To Import Alert

Nov 12 2018As background on August 10 2018 Cellectar announced that CPDC was informed of an FDA Import Alert that prohibited CPDC from supplying CLR 131 While the Import Alert disrupted CLR 131 supply the basis of the Import Alert was not related to CLR 131 specifically or to CPDC's production facility associated with CLR 131

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Clozaril FDA Alerts

Jan 28 2020Clozaril FDA Alerts The FDA Alert(s) below may be specifically about Clozaril or relate to a group or class of drugs which include Clozaril (clozapine) MedWatch Safety Alerts are distributed by the FDA and published by Drugs Following is a list of possible medication recalls market withdrawals alerts and warnings

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How To Get Off The FDA 'Black List'

Aug 03 2009To check if a company you are doing business with is on such a list check FDA's Import Alert page Y ou can search by country company etc If your company is on this list any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States

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FDA Issues Import Alert on Cantaloupes From Mexico

Today's import alert expands the prior import alerts that targeted specific shippers and growers whose products were linked to outbreaks or tested positive for Salmonella The FDA also announced today that it will continue to work with the Mexican government on a food safety program for production packing and shipping of fresh cantaloupes

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FDA Lifts Import Alert on GE Salmon

The U S Food and Drug Administration (FDA) has deactivated an import alert that prevented the introduction of genetically engineered (GE) salmon into interstate commerce The agency's statement indicates that it placed the ban in 2016 with the intention of

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Service Delays and Regulatory Updates

Alert: U S Import Details for USMCA Posted on May 18 2020 Alert: China and the U S Tariff Actions May 2020 Posted on May 14 2020 Alert: Introducing the United States-Mexico-Canada Agreement Posted on April 23 2020 Update: FDA Import Requirements for Personal Protective Equipment Posted on April 22 2020

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Import Alerts (FDA)

Getting placed on Import Alerts disrupts your supply chain and harms your reputation While the Food and Drug Administration (FDA) denies it – for legal reasons placement on an Import Alert means automatic detention for companies and countries whose goods the Food and Drug Administration (FDA) has previously refused

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FDA Issues Import Alert on Peninsular Malaysian Shrimp

Apr 18 2016Today the U S Food and Drug Administration (FDA) issued Import Alert 16-136 "Detention without Physical Examination of Aquacultured Shrimp and Prawns from Peninsular Malaysia Due to Presence of Drug Residues from Unapproved Animal Drugs or the Presence of Unsafe Food Additives " Import Alert 16-136 follows a massive increase in the number of shrimp entry lines refused by the FDA

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FDA Puts China Firm on Import Alert

Dec 20 2016FDA placed the facility located at Suzhong Trade of City Private Industrial Park Baoying County Yangzhou City Jiangsu Province on Import Alerts 66-40 and 99-32 on Sept 20 2016 According to the FDA warning letter a company representative refused to provide FDA

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