Inspections, Compliance, Enforcement, and Criminal Investigations
2000 Warning Letters
Recently Posted | 2012 | 2011 | 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 |
Tobacco Retailer Warning Letters
Warning Letters for 2000
Recently Posted | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996
* 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
Posted on May 26, 2009
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
---|---|---|---|---|
April 28, 2000 | Isner Jeffrey M. M.D. | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
April 27, 2000 | M Blesy Dairy | Florida District Office | Food/Cattle | N/A * |
April 27, 2000 | Doctor's Radiology Services | Dallas District Office | Mammography Standards | N/A * |
April 26, 2000 | Shelhigh Inc. | New Jersey District Office | Quality System Regulation/Uropatch/Medical Device Reporting Regulation | N/A * |
April 26, 2000 | CCL Custom Manufaturing Inc. | New England District Office | CGMP/Finished Pharmaceuticals | N/A * |
April 26, 2000 | MRI Institute of Maryland | Baltimore District Office | Mammography Standards | N/A * |
April 26, 2000 | Arlington Hospital | Baltimore District Office | Mammography Standards | N/A * |
April 26, 2000 | Med-Pro Inc. | Kansas City District Office | Human Drug Repacking Facility/cGMP | N/A * |
April 26, 2000 | RFB Latex Limited | Center for Devices and Radiological Health | Quality System Regulation/Examination Gloves | N/A * |
April 25, 2000 | Northeast Georgia Medical Center Inc. | Center for Biologics Evaluation and Research | IRB (Institutional Review Board) | N/A * |
April 25, 2000 | Stritzel Farm | Cincinnati District Office | Food/Cattle | N/A * |
April 25, 2000 | Barranquitas Ultrasound & Mammography Center | San Juan District Office | Mammography Standards | N/A * |
April 25, 2000 | Humboldt General Hospital | Nashville District Office | Mammography Standards | N/A * |
April 25, 2000 | Noah's Ark Animal Hospital | New York District Office | Food/Cattle | N/A * |
April 24, 2000 | Breast Center | Atlanta District Office | Mammography Standards | N/A * |
April 24, 2000 | North Georgia Medical Center | Atlanta District Office | Mammography Standards | N/A * |
April 24, 2000 | York Pharmaceutical Inc. | Kansas City District Office | OTC Drug Manufacturing Facility/cGMP | N/A * |
April 24, 2000 | Albemarle Hospital | Atlanta District Office | Mammography Standards | N/A * |
April 21, 2000 | Mobile Breast Care Services | Los Angeles District Office | Mammography Standards | N/A * |
April 21, 2000 | Pacific Coast Tissue Bank | Los Angeles District Office | Tissue Bank/Standard of Operation | N/A * |
April 20, 2000 | Tripath Imaging Inc. | Center for Devices and Radiological Health | AutoCyte PREP System/Promotional Claims | N/A * |
April 20, 2000 | Gerben Leyendekker Dairy | San Francisco District Office | Food/Cattle | N/A * |
April 19, 2000 | Adkinson N. Franklin Jr. M.D. | Center for Biologics Evaluation and Research | Clinical Investigator | N/A * |
April 19, 2000 | North Colorado Medical Center | Dallas District Office | Mammography Standards | N/A * |
April 19, 2000 | A & D Healthcare | New Orleans District Office | Medical Oxygen / CGMP | N/A * |
April 19, 2000 | Genesee Memorial Hospital | New York District Office | Mammography Standards | N/A * |
April 19, 2000 | Greeley Medical Clinic | Dallas District Office | Mammography Standards | N/A * |
April 19, 2000 | Parkway Hospital Inc. | Dallas District Office | Mammography Standards | N/A * |
April 19, 2000 | Seldom Rest Farm | New York District Office | Food/Cattle | N/A * |
April 19, 2000 | Allergan Inc. | Center for Devices and Radiological Health | AMO PhacoFlex II Intraocular Lens/Promotional Claims/Lacks Application for PMA/Misbranded etc. | N/A * |
April 18, 2000 | Kubus Inc. | Kansas City District Office | Artificial Insemination Aid/Unapproved New Animal Drug Application | N/A * |
April 18, 2000 | Mentholatum Co. Inc. | New York District Office | Migraine Ice/Unpproved Application for Premarket Approval | N/A * |
April 18, 2000 | Microvena Corporation | Minneapolis District Office | Quality System Regulation/Amplatz Thrombectomy Devices | N/A * |
April 18, 2000 | OmniCorder Technologies Inc. | Center for Devices and Radiological Health | BioScan/Promotional Claims | N/A * |
April 18, 2000 | Lew-Lin Farms | New York District Office | Food/Cattle | N/A * |
April 18, 2000 | Kham Seafood | New Orleans District Office | Seafood Processing Regulations/HACCP | N/A * |
April 17, 2000 | Irasan Complex | Center for Food Safety and Applied Nutrition | Seafood Processing Regulations/HACCP | N/A * |
April 17, 2000 | Sim-Med Ltd. | Center for Devices and Radiological Health | Laser Product Performance Standard | N/A * |
April 17, 2000 | Limberg Michael B. M.D. | Center for Devices and Radiological Health | Clinical Investigator | N/A * |
April 14, 2000 | Stone Mill Foods Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
April 14, 2000 | Mission Bay Memorial Hospital/Institutional Review Board | Center for Devices and Radiological Health | IRB (Institutional Review Board) | N/A * |
April 14, 2000 | LaserSight Technologies Inc. | Center for Devices and Radiological Health | LaserScan LSX Excimer Laser/Promotional Claims/Misbranded Etc./Unapproved Use | N/A * |
April 14, 2000 | Euclid Systems Corporation | Center for Devices and Radiological Health | Sponsor Obligations | N/A * |
April 13, 2000 | Harper Hospital DMC University Laboratories | Detroit District Office | Blood Bank/CGMP/Finished Pharmaceuticals | N/A * |
April 13, 2000 | St. Louis Women's Healthcare Group | Dallas District Office | Mammography Standards | N/A * |
April 12, 2000 | Tri-County Food Services | Cincinnati District Office | Seafood Processing Regulations/HACCP | N/A * |
April 12, 2000 | Satelec - Amadent | Center for Devices and Radiological Health | Glass Bead Dry Heat Sterilizer/Lacks Premarket Approval | N/A * |
April 12, 2000 | Euclid Systems Corporation | Baltimore District Office | Quality System Regulation/Contact Lenses | N/A * |
April 12, 2000 | Avon Hill Farms Inc. | Baltimore District Office | Food/Cattle | N/A * |
April 12, 2000 | Galveston Medical Supplies Inc. | Dallas District Office | CGMP/Liquid Oxygen/Adulterated | N/A * |
Contact FDA
Division of Freedom of Information (HFI-35)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857