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 June 18, 2013
|Letter Issue Date||Company Name||Issuing Office||Subject||Close Out Date|
|June 13, 2013||Huvepharma Inc||Kansas City District Office||Medicated Feed/Adulterated||Not Issued *|
|June 12, 2013||GS Medical Packaging Inc||Center for Devices and Radiological Health||Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded||Not Issued *|
|June 12, 2013||TYTEX SLOVAKIA S.R.O.||Center for Devices and Radiological Health||Medical Device Reporting Regulation/Misbranded||Not Issued *|
|June 11, 2013||Pro-White Llc||Center for Devices and Radiological Health||Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)||Not Issued *|
|June 11, 2013||Asahi Kasai Medical Co., Ltd.||Center for Devices and Radiological Health||Medical Device Reporting Regulation/Misbranded||Not Issued *|
|June 07, 2013||Alma Lasers, Inc.||Chicago District Office||Medical Device Reporting/Misbranded||Not Issued *|
|June 06, 2013||MEDINVENTS NV||Center for Devices and Radiological Health||Medical Device Reporting Regulation/Misbranded||Not Issued *|
|June 06, 2013||S Serra Cheese Company||Detroit District Office||CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions||Not Issued *|
|June 05, 2013||Baarda Farms||Seattle District Office||Illegal Drug Residue||Not Issued *|
|June 03, 2013||www.alstobacco.com||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded||Not Issued *|
|June 03, 2013||Roest Family Dairy||San Francisco District Office||Illegal Drug Residue||Not Issued *|
|May 28, 2013||RPG Life Sciences Limited||Center for Drug Evaluation and Research||CGMP/Finished Pharmaceuticals/Adulterated||Not Issued *|