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 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 *|