Inspections, Compliance, Enforcement, and Criminal Investigations
Types of Warning Letters on the FDA Website
- General FDA Warning Letters
- Tobacco Retailer Warning Letters
- Drug Marketing and Advertising Warning Letters (and Untitled Letters to Pharmaceutical Companies)
Topics on this Page:
- Ways to View/Browse Warning Letters
- More Information About Warning Letters Posted Here
- Recently Posted Warning Letters
Ways to View/Browse Warning Letters
- Review the list of recently posted warning letters below.
- Select the year from the list above in which the warning letter was issued, and browse the chronological list of warning letters on the linked page.
To find specific Warning Letters:
- Perform a simple search by entering criteria into the search box below.
- Perform an Advanced Search
- Use any of these "Browse" functions:
To download information about Warning Letters to an Excel document:
Use the Search and Export Warning Letters to Excel function.
- Warning letters posted before June 25, 2001, are in PDF format. Warning letters posted after that date are available in HTML format.
- Persons with disabilities having problems accessing PDF files may call 301-827-6567 for assistance.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain available additional information on the current status of an issue in a particular warning letter on this site, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
|Letter Issue Date||Company Name||Issuing Office||Subject||Close Out Date|
|August 28, 2014||Petaware||Florida District Office||New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated/Misbranded||Not Issued *|
|August 28, 2014||I'm a Little Teacup||Florida District Office||New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|August 28, 2014||Blanc du Blanc, Inc.||Florida District Office||New Animal Drug/CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|August 18, 2014||HUMAN SCIENCE FOUNDATION||Los Angeles District Office||Unapproved Drugs/Misbranded||Not Issued *|
|August 18, 2014||Simply Clean Air & Water Inc.||New England District Office||CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated||Not Issued *|
|August 15, 2014||Zions Rx Formulations Services LLC dba Rx Formuations Serv.||Los Angeles District Office||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|August 14, 2014||Big Easy Confections, L.L.C.||New Orleans District Office||CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated||Not Issued *|
|August 13, 2014||www.nefsak.com||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|August 12, 2014||Ad-Med Biotechnology, LLC||Detroit District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|August 12, 2014||The Compounding Shop, Inc.||Florida District Office||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|August 12, 2014||Masimo Corporation||Los Angeles District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|August 08, 2014||Childrens Medical Ventures||Philadelphia District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|August 08, 2014||EnerHealth Botanicals, LLC||Denver District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|August 07, 2014||Explora Laboratories||Center for Drug Evaluation and Research||Generic Drug User Fee Amendments of 2012 (GDUFA)||Not Issued *|
|August 07, 2014||Colgate Oral Pharmaceuticals, Inc.||Center for Drug Evaluation and Research||Generic Drug User Fee Amendments of 2012 (GDUFA)||August 21, 2014|
|August 07, 2014||Korea United Pharm||Center for Drug Evaluation and Research||Generic Drug User Fee Amendments of 2012 (GDUFA)||Not Issued *|
|August 01, 2014||Geetanjali Inc., d/b/a Tobacco World||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|August 01, 2014||Peter Bacle dba Stock Island Lobster Company||Florida District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|July 25, 2014||William Rausch||Cincinnati District Office||Illegal Drug Residue||Not Issued *|
|July 18, 2014||Calaire Chimie S.A.S.||Center for Drug Evaluation and Research||Generic Drug User Fee Amendments of 2012 (GDUFA)||Not Issued *|