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|
|November 20, 2014||New Hope Fertility Center||New York District Office||Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)||Not Issued *|
|November 19, 2014||Floyd Raber||Cincinnati District Office||Illegal Drug Residue||Not Issued *|
|November 17, 2014||Walnut Creek Kitchens, Inc.||Cincinnati District Office||CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|November 14, 2014||Martin Star Dairy||Philadelphia District Office||Illegal Drug Residue||Not Issued *|
|November 12, 2014||Pagano's Inc.||New England District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|November 10, 2014||Wells Pharmacy Network LLC||Florida District Office||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|November 07, 2014||Excelsior Medical Corp||New Jersey District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|November 07, 2014||Nemschoff Chairs, Inc.||Minneapolis District Office||Medical Device Reporting/Misbranded||Not Issued *|
|November 04, 2014||Navilyst Medical, Inc.||New York District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|November 03, 2014||Avena Botanicals, Inc.||New England District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|October 29, 2014||Eastern Pharmacy, Inc.||Florida District Office||Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|September 15, 2014||Pleasant View Dairy||Kansas City District Office||Illegal Drug Residue Animal Tissue/Adulterated||Not Issued *|