Warning Letters

Recently Posted | 2013 | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 |

Tobacco Retailer Warning Letters

 

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)

Read more about types of warning letters

Topics on this Page: 

• Ways to View/Browse Warning Letters
• More Information About Warning Letters Posted Here
• Recently Posted Warning Letters

---

Sign Up to Receive Warning Letter Updates

---

Ways to View/Browse Warning Letters

To view Warning Letters by date:

• Review the list of recently posted warning letters below.

Or:

• 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.

 

 

• Or:

  • Perform an Advanced Search
  • Use any of these "Browse" functions:
    • Browse Warning Letters by Company
    • Browse Warning Letters by Issuing Office
    • Browse Warning Letters by Subject
    • Browse Warning Letters with Response Letters
    • Browse Warning Letters with Closeout Letters

  To download information about Warning Letters to an Excel document:

  • Use the Search and Export Warning Letters to Excel function.

  ---

  More Information about Warning Letters Posted Here

  • 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.

  ---

  Recently Posted Warning Letters

 

 

Posted on May 21, 2013

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
May 14, 2013	Whatsa Bagel, Inc.	Baltimore District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
May 13, 2013	Robert L. Honeycutt	Cincinnati District Office	Illegal Drug Residue	Not Issued *
May 09, 2013	Kronner Prototypes, Inc	Seattle District Office	Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)	Not Issued *
May 09, 2013	Hospira Inc.	Chicago District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
May 06, 2013	Boehringer Ingelheim Pharma GMBH & Co	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated	Not Issued *
May 02, 2013	Alternative Health Supplements	Detroit District Office	Unapproved and Misbranded New Drugs	Not Issued *
May 01, 2013	Riverpoint Medical, LLC	Seattle District Office	CGMP/QSR/Medical Devices/Adulterated/Misbranded	Not Issued *
April 26, 2013	V-SAB Medical Labs, Inc.	Atlanta District Office	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded	Not Issued *
April 26, 2013	ACell, Inc	Baltimore District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
April 24, 2013	Glucorell, Inc. / Anafit, Inc.	Florida District Office	Unapproved and Misbranded New Drugs	Not Issued *
April 11, 2013	Realm Labs, LLC	Florida District Office	Unapproved and Misbranded New Drugs	Not Issued *
April 08, 2013	Body Systems Inc.	Florida District Office	Unapproved and Misbranded New Drugs	Not Issued *
April 02, 2013	Natures Health Options LLC	Florida District Office	Unapproved and Misbranded New Drugs	Not Issued *
March 19, 2013	Innovative Med Inc.	Los Angeles District Office	CGMP/QSR/Medical Devices/Adulterated	Not Issued *
March 04, 2013	Correia Family Limited Partnership (dba Wynsum Holsteins)	New England District Office	Illegal Drug Residue	Not Issued *
January 30, 2013	Pishon Trading Inc	Los Angeles District Office	Medical Device Reporting/Misbranded	Not Issued *
January 15, 2013	Spence & Co., Ltd.	New England District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *

• Previous
• 1
• Next