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  6. Warning Letters 2020
  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Warning Letters 2020

These letters are supplied by the CDER Freedom of Electronic Information Office. This page only covers Office of Prescription Drug Promotion and CDER Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.     

If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to: 

Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857

Instructions for how to submit an FOI request can be found on the FDA Freedom of Information Page.

Office of Prescription Drug Promotion

Company/Individual

Product/Issue

Issue Date

Outlook Pharmaceuticals, Inc.

ANDA 040776 PROCENTRA® (dextroamphetamine sulfate) oral solution, CII

2/21/2020

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Office of Compliance/Immediate Office 

Company/Individual

Product/Issue

Issue Date

 

   

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Office of Manufacturing Quality

Company/Individual

Product/Issue

Issue Date

Windlas Healthcare Private Limited

CGMP/Finished Pharmaceuticals/Adulterated 3/10/2020

Yibin Lihao Bio-technical Co., Ltd.

CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated 2/13/2020

Sunstar Guangzhou Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 1/22/2020

Dental-Kosmetik GmbH & Co. KG

CGMP/Finished Pharmaceuticals/Adulterated 1/16/2020

Cosmelab Co Ltd

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

Zhuhai Aofute Medical Technology Co., Ltd.

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

Huaian Zongheng Bio-Tech Co., Ltd

CGMP/Finished Pharmaceuticals/Adulterated 1/9/2020

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Office of Scientific Investigations

Company/Individual

Product/Issue

Issue Date

 

   

 

Office of Unapproved Drugs and Labeling Compliance

Company/Individual

Product/Issue

Issue Date

Noetic Nutraceuticals

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/15/2020

The Golden Road Kratom

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/15/2020

White Eagle Native Herbs

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/14/2020

benjaminmcevoy.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/14/2020

Fusion Health and Vitality LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/11/2020

Plum Dragon Herbs, Inc.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/8/2020

Seanjari Preeti Womb Healing, L.L.C.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/8/2020

AgroTerra, Ltd. dba Patriot Hemp Company

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/7/2020

WashingtonsLastFrontier.Com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/7/2020

Chronic Lyme Treatment

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/7/2020

Sanit Technologies LLC dba Durisan

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/7/2020

Alive By Nature, Inc.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/6/2020

GlutaGenic

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/6/2020

Dr. Dhole's Sushanti Homeopathy Clinic

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/4/2020

Honey Colony LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/4/2020

Hopewell Essential Oils

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/27/2020

Santiste Labs LLC

Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) 4/27/2020

Prefense LLC

Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19) and Other Diseases 4/23/2020

Antroids.com

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet 4/22/2020

Foxroids.com

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID-19) to United States Consumers Over the Internet    4/22/2020

Copper Touch, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/21/2020

Homero Corp DBA Natures CBD Oil Distribution

Unapproved and Misbranded products containing cannabidiol (CBD) 4/20/2020

Nova Botanix LTD DBA CanaBD

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/16/2020

The Art Of Cure

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/15/2020

Earth Angel Oils

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/14/2020

The GBS dba Alpha Arogya India Pvt Ltd

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/13/2020

Gaia Arise Farms Apothecary

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/13/2020

Herbs of Kedem

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/10/2020

BIOTA Biosciences LLC

Unapproved and Misbranded Products 4/9/2020

Earthley Wellness dba Modern Alternative Mama LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/9/2020

Free Speech Systems LLC d.b.a. Infowars.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/9/2020

NRP Organics Ltd

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/8/2020

Genesis 2 Church

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/8/2020

Savvy Holistic Health dba Holistic Healthy Pet

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/7/2020

CBD Online Store

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/7/2020

Ananda, LLC DBA Ananda Apothecary

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Native Roots Hemp

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Indigo Naturals

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Cathay Natural, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Alternative Health Experts LLC DBA Immunization Alternatives

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/6/2020

Health Mastery Systems DBA Pure Plant Essentials

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/1/2020

Homeomart Indibuy

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/1/2020

Gaia's Whole Healing Essentials, LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 4/1/2020

NeuroXPF

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/31/2020

Unitedpharmacies.md

Notice of Unlawful Sale of Unapproved and Misbranded Drugs Related to Coronavirus Disease 2019 (COVID‐19) to United States Consumers Over the Internet 3/30/2020

JRB Enterprise Group Inc. DBA Anti Aging Bed

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/30/2020

Halosense Inc.

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/30/2020

Bioactive C60/FullerLifeC60 LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/30/2020

Carahealth

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/26/2020

Corona-cure.com

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)           3/26/2020

Quinessence Aromatherapy LTD

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

GuruNanda LLC

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

Colloidal Vitality LLC/Vital Silver

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

Xephyr, LLC dba N-Ergetics

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

Vivify Holistic Clinic

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 3/6/2020

Office of Drug Security, Integrity and Recalls

Company/Individual

Product/Issue

Issue Date

 

   

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