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 December 03, 2013
|Letter Issue Date||Company Name||Issuing Office||Subject||Close Out Date|
|November 25, 2013||Johnson Farm LLC||New York District Office||Illegal Drug Residue||Not Issued *|
|November 25, 2013||Fresh Directions Dominicana||Center for Food Safety and Applied Nutrition||Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|November 25, 2013||Wockhardt Limited||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|November 22, 2013||Vendors Unlimited Corporation||Kansas City District Office||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|November 20, 2013||Hyperion Medical||Center for Devices and Radiological Health||Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)||Not Issued *|
|November 20, 2013||Shoney Scientific India||Center for Devices and Radiological Health||Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)||Not Issued *|
|November 18, 2013||SYNECCO LTD.||Center for Devices and Radiological Health||CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated||Not Issued *|
|November 07, 2013||HONG NGOC PTE||Center for Food Safety and Applied Nutrition||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|October 04, 2013||Allergy Laboratories, Inc.||Office of Regulatory Affairs||CGMP Deviations||Not Issued *|
|August 30, 2013||Lucky Fortune Cookies, Inc.||Baltimore District Office||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|June 21, 2013||Celtrock Holdings Limited||Center for Food Safety and Applied Nutrition||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|April 15, 2013||Bubbas Fish House||Cincinnati District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|