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.
Posted on May 14, 2013
|Letter Issue Date||Company Name||Issuing Office||Subject||Close Out Date|
|May 08, 2013||Entrenet Nutritionals, Inc.||Philadelphia District Office||Unapproved and Misbranded New Drugs||Not Issued *|
|May 06, 2013||Rubimed AG||Center for Devices and Radiological Health||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|May 03, 2013||SmartPractice||Center for Biologics Evaluation and Research||False & Misleading Claims/Misbranded||Not Issued *|
|May 02, 2013||WEBER MEDICAL GMBH||Center for Devices and Radiological Health||Quality System Regulation for Medical Devices/Adulterated||Not Issued *|
|May 01, 2013||Dale Schmitmeyer Farm||Cincinnati District Office||Illegal Drug Residue||Not Issued *|
|April 30, 2013||Electromedical Products International, Inc||Dallas District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|April 30, email@example.com||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|April 30, 2013||http://www.cigarettes-info.com||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|April 25, 2013||Shippert Medical Technologies||Denver District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|April 16, 2013||Emrich Farms||Philadelphia District Office||Illegal Drug Residue||Not Issued *|
|April 02, 2013||Juve International, LLC||Denver District Office||New Drug/Labeling/False & Misleading Claims||Not Issued *|
|March 01, 2013||Desert Rose Manufacturing||Denver District Office||CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated||Not Issued *|
|February 28, 2013||Interlab S.r.l.||Center for Devices and Radiological Health||Medical Devices/Adulterated||Not Issued *|
|February 20, 2013||Carrizozo Orchard||Denver District Office||Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|