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|
|August 15, 2016||College Pharmacy Incorporated||Denver District Office||CGMP/Finished Pharmaceuticals/Adulterated/Misbranded||Not Issued *|
|August 15, 2016||Frontida BioPharm Inc||Philadelphia District Office||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|August 12, 2016||Unimark Remedies Limited||Center for Drug Evaluation and Research||CGMP/Active Pharmaceutical Ingredient (API)/Adulterated||Not Issued *|
|August 12, 2016||Cape Apothecary, Inc.||Baltimore District Office||Unapproved New Drug/Compounding/Misbranding/Adulterated||Not Issued *|
|August 10, 2016||O. Scott Wayment Dairy, Inc.||Denver District Office||Illegal Drug Residue||Not Issued *|
|August 10, 2016||Phillip Thompson||Baltimore District Office||Illegal Drug Residue||Not Issued *|
|August 10, 2016||Huzhou Aupower Sanitary Commodity||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|August 09, 2016||Jeni's Splendid Ice Creams, LLC||Cincinnati District Office||CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions||Not Issued *|
|August 05, 2016||Tosoh Bioscience Inc||Cincinnati District Office||CGMP/QSR/Medical Devices/Adulterated||Not Issued *|
|July 15, 2016||Aloe Farms, Inc||Dallas District Office||Acidified Foods/Emergency Permit Control/Adulterated/Misbranded||Not Issued *|