04/28/2020

04/14/2020

T & S Dairy

Division of Human and Animal Food Operations West III

Illegal Drug Residue

04/28/2020

04/27/2020

Hopewell Essential Oils

Center for Drug Evaluation and Research | CDER

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

04/28/2020

04/27/2020

Santiste Labs LLC

Center for Drug Evaluation and Research | CDER

Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19)

04/27/2020	04/27/2020	Dukhan Store	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/27/2020	04/27/2020	Wizman Limited	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/27/2020	04/27/2020	VapeSourcing	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/27/2020	04/27/2020	VapeCentric, Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

04/27/2020	04/27/2020	Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/27/2020	04/27/2020	Vape Royalty, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/27/2020	04/27/2020	Vaprwear Gear, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/27/2020	04/27/2020	Ejuicepack, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/27/2020	04/27/2020	EightCig LLC d/b/a EightCig Distribution	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
04/27/2020	04/27/2020	Vapewear, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

LabCorp's at-home coronavirus testing kit authorized by FDA

LabCorp's at-home coronavirus testing kit authorized by FDA

FDA Warns Manufacturers and Retailers to Remove Certain E-cigarette Products Targeted to Youth from the Market

Agency Continues to Target the Sale of Unauthorized, Flavored E-cigarette Products That Appeal to Youth

Today, the U.S. Food and Drug Administration issued ten warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth. The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner. Warning letters were also issued to...

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FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure

Today, the U.S. Food and Drug Administration issued a letter to Bayer outlining conditions for submitting additional postmarket information to the agency about Essure—a permanent birth control device Bayer sold in the U.S. until 2018. The letter applies to reportable adverse events Bayer is or becomes aware of from social media information received in relation to ongoing litigation regarding Essure. Because of the anticipated volume and nature of this information, the FDA granted Bayer’s request for a variance from some medical device reporting requirements but imposed conditions for reporting to ensure protection of the public health. Under the conditions, Bayer is required to ...

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Johnson & Johnson sets stage for COVID-19 shot rollout with 'first in a series' manufacturing deal

Johnson & Johnson sets stage for COVID-19 shot rollout with 'first in a series' manufacturing deal

India pharma manufacturing hub back up and running after COVID-19 lockdown: report

India pharma manufacturing hub back up and running after COVID-19 lockdown: report