Inspections, Compliance, Enforcement, and Criminal Investigations
2000 Warning Letters
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Warning Letters for 2000
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* 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 |
---|---|---|---|---|
May 16, 2000 | Quality Fruits Products Corp. | San Juan District Office | Food Product Manufacturing Facitity/Labeling | N/A * |
May 15, 2000 | Rifton Aviation Services | New York District Office | Control of Communicable Diseases and Interstate Conveyance Regulations Violations | N/A * |
May 15, 2000 | Ferolito Vultaggio & Sons Inc. | Center for Food Safety and Applied Nutrition | Arizona Rx Stress Relief Elixir/Misbranded/Labeling | N/A * |
May 12, 2000 | Whole Living Inc. | Denver District Office | Progesterone cream/New Drug/Labeling/Misbranded | N/A * |
May 12, 2000 | Wa Heng Dou Fu Soy Sauce Int Enterprises | San Francisco District Office | Insanitary Practices & Conditions | N/A * |
May 12, 2000 | Pacific Harvest Products Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
May 12, 2000 | Zarda King Ltd. | Chicago District Office | Food Products Storage/Insanitary Conditions | N/A * |
May 12, 2000 | Sandwich Shoppe | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
May 11, 2000 | Focus Imaging Group Inc. | Florida District Office | Diagnostic Ultrasound Equipment/Lacks Premarket Approval/Misbranded | N/A * |
May 11, 2000 | Euthenics International Inc. | Denver District Office | Trandermal Delivery System/New Drug | N/A * |
May 11, 2000 | International Imaging Electronics Inc. | Chicago District Office | Quality System Regulation/Medical Imaging Electronic Equipment | N/A * |
May 10, 2000 | Paragon Implant Company | Center for Devices and Radiological Health | Paragon Swiss Plus Implant System/Promotional Claims/Lacks Approved Pre-market Application | N/A * |
May 10, 2000 | Dean Health System Inc. | Minneapolis District Office | Mammography Standards | N/A * |
May 10, 2000 | Home Care Equipment Inc. | Baltimore District Office | Medical Gases / CGMP | N/A * |
May 10, 2000 | South Bend Packers Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
May 10, 2000 | Hocking Valley Community Hospital | Cincinnati District Office | Mammography Standards | N/A * |
May 09, 2000 | Petersburg Medical Center | Seattle District Office | Mammography Standards | N/A * |
May 09, 2000 | Wheeler Seafoods Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
May 09, 2000 | KV Pharmaceutical Company | Kansas City District Office | Drug Manufacturing Operations/CGMP deviations | N/A * |
May 09, 2000 | Interim Penn Memorial Hospital | Atlanta District Office | Mammography Standards | N/A * |
May 09, 2000 | Louisiana Substance Abuse Clinic Inc. | New Orleans District Office | Narcotic Treatment Standards Violations | N/A * |
May 09, 2000 | Posey Crab Company | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
May 08, 2000 | Schering-Plough Laboratories | San Juan District Office | Human Veterinary Pharmaceutical Manufacturing Facility/CGMP/Finished Pharmaceuticals | N/A * |
May 08, 2000 | Newport Hospital and Clinic | Dallas District Office | Mammography Standards | N/A * |
May 08, 2000 | Valley National Gases Inc. | New Jersey District Office | Finished Pharmaceuticals/Oxygen Repackaging Facility/CGMP | N/A * |
May 08, 2000 | Vista Mundo Inc. | Florida District Office | St. Lucia Eye Drops/Lacks Approved New Drug Application/Promotional Claims/Labeling/Misbranded | N/A * |
May 08, 2000 | DBA Get Huge | Los Angeles District Office | Trican (tiratricol)/Unapproved New Drug Application/Misbranded/Not a Dietary Supplement | N/A * |
May 08, 2000 | Biosil Limited | Center for Devices and Radiological Health | Medical Devices Regulation/Saline Fill Mammary Implants | N/A * |
May 08, 2000 | MedGyn Products Inc. | Chicago District Office | Quality System Regulation/ Obstetrical & Gynecological Devices | N/A * |
May 08, 2000 | Gulf Go-Fers Incorporated | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
May 05, 2000 | Chattanooga Diagnostic Imaging | Nashville District Office | Mammography Standards | N/A * |
May 05, 2000 | Enzymatic Therapy Inc. | Minneapolis District Office | Glucosamine Sulfate & Nasal Decongestant Products/Lacks Approved NDA/Misbranded/Labeling | N/A * |
May 05, 2000 | Taku Smokeries/Fisheries | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
May 05, 2000 | South Jersey Radiology Associates P.A. | New Jersey District Office | Mammography Standards | N/A * |
May 05, 2000 | Lee Memorial Hospital Blood Band | Florida District Office | Blood Band & Laboratory/CGMP/Blood & Blood Component Regulations | N/A * |
May 05, 2000 | Thames Pharmacal Co. Inc. | New York District Office | CGMP/Finished Pharmaceuticals | N/A * |
May 04, 2000 | Dhanraj | San Francisco District Office | Insanitary Conditions | N/A * |
May 04, 2000 | Mofel's Food International Corporation | Center for Food Safety and Applied Nutrition | Seafood Processing Regulations/HACCP | N/A * |
May 04, 2000 | Kershaw County Medical Center | Atlanta District Office | Mammography Standards | N/A * |
May 03, 2000 | Health Plus Medical Group | Dallas District Office | Mammography Standards | N/A * |
May 03, 2000 | Business Express Airlines | New York District Office | Interstate Conveyance Sanitation Regulation Deficiencies | N/A * |
May 03, 2000 | Golden Plains Community Hospital | Dallas District Office | Mammography Standards | N/A * |
May 02, 2000 | Nelson and Sons Inc. | Denver District Office | Medicated Feeds/CGMP | N/A * |
May 02, 2000 | Dhanraj | San Francisco District Office | Insanitary Conditions | N/A * |
May 02, 2000 | Rich Lou Farm | Philadelphia District Office | Food/Cattle | N/A * |
May 01, 2000 | Margaret Mary Community Hospital | Detroit District Office | Mammography Standards | N/A * |
April 30, 2000 | Tyler Donnie | Cincinnati District Office | Food/Cattle | N/A * |
April 28, 2000 | Reinauer Transportation Co. | New York District Office | Vessel Watering Points | N/A * |
April 28, 2000 | Albert Lea Medical Center | Minneapolis District Office | Mammography Standards | N/A * |
April 28, 2000 | Advanced Health CAre | Minneapolis District Office | Mammography Standards | N/A * |
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