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|
|September 11, 2014||4cigarettes.net||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|September 04, 2014||John W Hollis Inc||New Orleans District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|September 03, 2014||Wabash Way Holsteins, LLC||Cincinnati District Office||Illegal Drug Residue||Not Issued *|
|August 29, 2014||Glenville Farms||Philadelphia District Office||Illegal Drug Residue||Not Issued *|
|August 27, 2014||Health Science Products Inc||New Orleans District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|August 26, 2014||OrgSyn Laboratory Inc||Center for Drug Evaluation and Research||Generic Drug User Fee Amendments of 2012 (GDUFA)||Not Issued *|
|August 21, 2014||Lynn Born||Dallas District Office||Illegal Drug Residue||Not Issued *|
|August 19, 2014||Descor LLC||Baltimore District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|June 30, 2014||Advanced MicroVas II, LLC||Dallas District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|May 20, 2014||BEK Catering, LLC dba Floppers Foods||New Orleans District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|