Inspections, Compliance, Enforcement, and Criminal Investigations
2009 Warning Letters
Recently Posted | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996
Warning Letters issued in 2009
* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.
* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.
Read more about warning and close-out letters
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
|---|---|---|---|---|
| November 03, 2009 | Texas Wholesale | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | Rokok Zone | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | Durango Smoke Shop, Inc. | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | Amsterdam Tobacco Co | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | H.J. Bailey Co. | Center for Tobacco Products | Tobacco Products/Adulterated | Not Issued * |
| November 03, 2009 | Euro-Cigs | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | Clove Cigarettes Shop | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | Chavez, Inc. | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | Heavenly Smoke Inc | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 03, 2009 | Algisiya Servicesz Limited | Center for Tobacco Products | Tobacco Products/Adulterated | Not Issued * |
| November 02, 2009 | Li Ning | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 02, 2009 | Han, Jeffrey | Center for Tobacco Products | Tobacco Products/Adulterated | Not Issued * |
| November 02, 2009 | Smoke Shop USA Ltd | Center for Tobacco Products | Tobacco Products/Adulterated/Misbranded | Not Issued * |
| November 02, 2009 | Lim Sin Wei | Center for Tobacco Products | Tobacco Products/Adulterated | Not Issued * |
| October 29, 2009 | Procter and Gamble | Center for Drug Evaluation and Research | OTC Drug Products/Dietary Supplements/Misbranded | Not Issued * |
| October 28, 2009 | Stew Leonard's Holdings LLC | New England District Office | Food Labeling/False & Misleading Claims/Misbranded | Not Issued * |
| October 28, 2009 | Perry Veterinary Clinic | New York District Office | Extralabel Drug Use in Animals/Adulterated | Not Issued * |
| October 23, 2009 | McKay, Charles M.D. | Center for Drug Evaluation and Research | Clinical Investigator | Not Issued * |
| October 21, 2009 | Minatare Feed Lot Inc | Kansas City District Office | CGMP for Medicated Feeds/Adulterated | Not Issued * |
| October 16, 2009 | Trilogy Crab Co. Inc. | Seattle District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| October 16, 2009 | Schwarz Fish Co. | Minneapolis District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
| October 16, 2009 | Pacific American Fish Co., Inc | New England District Office | CGMP for Foods/Seafood HACCP/Adulterated | Not Issued * |
| October 15, 2009 | Cold Cut Kruise, Inc. | Detroit District Office | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
| October 15, 2009 | Weil Lifestyle LLC | Center for Biologics Evaluation and Research | Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus | Not Issued * |
| October 14, 2009 | J & V Dairy, LLC | Seattle District Office | Animal Sale for Slaughter as Food/Adulterated | Not Issued * |
| October 13, 2009 | Cerovene, Inc. | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
| October 13, 2009 | DAVA Pharmaceuticals, Inc. | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
| October 13, 2009 | Myojo USA, Inc. | Los Angeles District Office | Acidified Foods/Emergency Permit Control/Adulterated | Not Issued * |
| October 13, 2009 | Dynamic Surgery, Inc. 10/13/09 | New England District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| October 13, 2009 | Lehigh Valley Technologies, Inc. 10/13/09 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
| October 13, 2009 | Glenmark Pharmaceuticals Inc. USA 10/13/09 | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded | Not Issued * |
| October 09, 2009 | Philips Healthcare Inc. 10/9/09 | New England District Office | CGMP/QSR/Medical Devices/Adulterated | Not Issued * |
| October 09, 2009 | TLC Laser Eye Centers | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | TLC Laser Eye Center d/b/a TLC Pittsburgh | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | LCA Vision Inc | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | TLC Laser Eye Centers | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | Evergreen Acres | Minneapolis District Office | Animal Sale for Slaughter as Food/Adulterated | Not Issued * |
| October 09, 2009 | Pacific Nutritional Foods, Inc. | Seattle District Office | Low Acid Canned Food Regulation/Adulterated | Not Issued * |
| October 09, 2009 | LasikPlus Vision Center | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | Lasik Vision Institute | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | Lasik Vision Institute | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | LCA Vision, Inc | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | Lasik Vision Institute | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | Lasik Vision Institute | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | LasikPlus | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | LasikPlus Vision Center | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | LCA Vision Inc. | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | TLC Laser Eye Centers | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | Laser Eye Care of California | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
| October 09, 2009 | Lasik Plus | Center for Devices and Radiological Health | Medical Device Reporting Regulation/Misbranded | Not Issued * |
Contact Us
ICECI Warning Letters
Division of Freedom of Information (HFI-35)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

