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|
|October 19, 2016||Colabs Intl Corp||San Francisco District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|October 19, 2016||ITW Dymon||Kansas City District Office||Drug Product/OTC/Unapproved New Drug||Not Issued *|
|October 19, 2016||Diamond Wipes International, Inc.||Los Angeles District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|October 19, 2016||Meditech Laboratories, Inc||San Francisco District Office||Drug Product/Adulterated||Not Issued *|
|October 18, 2016||SCS Direct Inc.||New England District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|October 18, 2016||PhytoCeuticals, Inc.||New Jersey District Office||Unapproved New Drugs/Misbranded||Not Issued *|
|October 18, 2016||Interpharm Praha A.S.||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|October 14, 2016||JD & SN Inc., dba Moses Lake Professional Pharmacy||Seattle District Office||Compounding Pharmacy/Unapproved New Drug/Misbranded/Adulterated||Not Issued *|
|October 13, 2016||Teva Pharmaceutical Works Private Limited Company||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|
|October 12, 2016||Threshold Enterprises Ltd||San Francisco District Office||CGMP/Dietary Supplement/Adulterated/Misbranded||Not Issued *|
|October 04, 2016||Seaquest Seafood Corporation||Los Angeles District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|September 30, 2016||Shining Marble Inc dba Shil La Dang||Los Angeles District Office||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|September 27, 2016||Osea Internacional||Los Angeles District Office||New Drug/Labeling/False & Misleading Claims||Not Issued *|
|September 27, 2016||Proprietary Wellness LLC||Cincinnati District Office||Dietary Supplement/Misbranded||Not Issued *|
|September 20, 2016||Buderer Drug Company Inc||Cincinnati District Office||Compounding Pharmacy/Adulteration/Misbranding||Not Issued *|
|September 20, 2016||Face Naturals||Center for Food Safety and Applied Nutrition||New Drug/Labeling/False & Misleading Claims||October 18, 2016|
|September 07, 2016||Hans Zipperle, S.p.A.||Center for Food Safety and Applied Nutrition||Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions||Not Issued *|
|August 10, 2016||Perfect Source Natural Products Inc.||Los Angeles District Office||CGMP/Dietary Supplement/Adulterated||Not Issued *|
|July 29, 2016||NuVet Labs||Los Angeles District Office||New Animal Drug/Adulterated||Not Issued *|
|July 25, 2016||Right Value Drug Stores, Inc.||Dallas District Office||CGMP/Finished Pharmaceuticals/Adulterated/Misbranded||Not Issued *|