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 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.
- 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), 5630 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|
|May 28, 2015||Foo Yuan Food Products||New York District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|May 27, 2015||VUAB Pharma a.s.||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|May 27, 2015||Adamba Imports International Inc.||New York District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|May 21, 2015||Pharmakon Pharmaceuticals||Detroit District Office||Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|May 21, 2015||Insightra Medical Inc||Los Angeles District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|May 21, 2015||Bowman Dairy Farms Llc||Detroit District Office||Illegal Drug Residue||Not Issued *|
|May 19, 2015||9mm Special Effects||San Francisco District Office||CGMP/QSR/Medical Devices/Adulterated/Misbranded||Not Issued *|
|May 15, 2015||LiquidCapsule Manufacturing, LLC||Florida District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|May 14, 2015||HHCS Pharmacy, Inc., dba Freedom Pharmacy||Florida District Office||Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|April 30, 2015||Soft Computer Consultants, Inc.||Florida District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|April 27, 2015||Premier Pharmacy Labs Inc||Florida District Office||Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated||Not Issued *|
|December 24, 2014||Nuga Medical Co., Ltd.||Center for Devices and Radiological Health||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|