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 |
---|---|---|---|---|
March 15, 2000 | Signature Flight Support | Baltimore District Office | Interstate Conveyance Sanitation Regulation Deficiencies | N/A * |
March 15, 2000 | Genesist Inc. | Denver District Office | Amino Acid/Dietary Supplements/Labeling | N/A * |
March 15, 2000 | Medical Associates of Gallipolis Inc. | Cincinnati District Office | Mammography Standards | N/A * |
March 15, 2000 | Radiology Diagnostic Center | Los Angeles District Office | Mammography Standards | N/A * |
March 14, 2000 | Newport Seafoods Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
March 14, 2000 | Bales Scientific Inc. | Center for Devices and Radiological Health | Thermal Image Processor Photonic Stimulator/Lacks Premarket Approval/Promotional Claims | N/A * |
March 14, 2000 | Jenkins Community Hospital | Cincinnati District Office | Mammography Standards | N/A * |
March 14, 2000 | Pacific Coast Medical Services | Los Angeles District Office | Mammography Standards | N/A * |
March 14, 2000 | University of Utah Health Network - Mt. Ogden Center | Dallas District Office | Mammography Standards | N/A * |
March 14, 2000 | Kim Yeongcheol M.D. | New York District Office | Mammography Standards | N/A * |
March 14, 2000 | Wyoming Medical Center | Dallas District Office | Mammography Standards | N/A * |
March 13, 2000 | Tri-City Outpatient Imaging | Los Angeles District Office | Mammography Standards | N/A * |
March 13, 2000 | McKinley Medical LLLP | Denver District Office | Quality System Regulations/Infusion Pumps & Infusion Tubing Sets | N/A * |
March 13, 2000 | Safe Harbor Seafood Inc. | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
March 13, 2000 | Green Mountain Smoked Salmon | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
March 13, 2000 | Ponderosa Dairy | San Francisco District Office | Food/Cattle | N/A * |
March 13, 2000 | Spiess Design Inc. | Chicago District Office | Quality System Regulation/Endoscopes & Bipolar Forceps | N/A * |
March 13, 2000 | Frank J. Gomes Dairy | San Francisco District Office | Food/Cattle | N/A * |
March 10, 2000 | Center Laboratories Inc. | Office of Enforcement | GMP for Mfr Processing Packing Holding Drugs/Reporting Biological Products Deviations | N/A * |
March 10, 2000 | PrimeCare Medical Group | Los Angeles District Office | Mammography Standards | N/A * |
March 10, 2000 | Clinica Medica General - Huntington Park | Los Angeles District Office | Mammography Standards | N/A * |
March 10, 2000 | Thoratec Laboratories Corporation | San Francisco District Office | Quality System Regulation/Thoratec Ventricular Assist Device System | N/A * |
March 10, 2000 | Clinica Medica General - East L.A. | Los Angeles District Office | Mammography Standards | N/A * |
March 10, 2000 | KPC Medical Management Inc. | Los Angeles District Office | Mammography Standards | N/A * |
March 09, 2000 | Florida Smoked Fish Co. | Philadelphia District Office | Seafood Processing Regulations/HACCP | N/A * |
March 09, 2000 | Home Care Medical Equipment Inc. | Nashville District Office | Medical Oxygen / CGMP | N/A * |
March 09, 2000 | Greer Laboratories Inc. | Center for Biologics Evaluation and Research | Allergenic Extract/Finished Pharmaceuticals/Manufacturing/Holding & Processing | N/A * |
March 09, 2000 | Blue & White Food Products Corp. | New York District Office | Seafood Processing Regulations/HACCP | N/A * |
March 09, 2000 | Great Lakes College of Clinical Medicine IRB | Center for Biologics Evaluation and Research | IRB (Institutional Review Board) | N/A * |
March 09, 2000 | MedNet Services Inc. | Minneapolis District Office | Quality System Regulation/Interferential Nerve & Muscle Stimulator Device | N/A * |
March 09, 2000 | Celletech Ltd. | Minneapolis District Office | Tetanus/LM1 Nux Vomica & Udder Symptom/Lacks Premarket Approval/Misbranding | N/A * |
March 08, 2000 | Back To Nature Inc. | Chicago District Office | Dietary Supplements/Labeling/Misbranded | N/A * |
March 08, 2000 | Oxygen Therapy Institute | Detroit District Office | Berman Resusi CPR Mask/Lacks Premarket Approval | N/A * |
March 08, 2000 | Schell John E. | New York District Office | Food/Cattle | N/A * |
March 08, 2000 | New York Medical Group P.C. | New York District Office | Mammography Standards | N/A * |
March 08, 2000 | Carenet Medical Group | New York District Office | Mammography Standards | N/A * |
March 08, 2000 | Select Fish L.L.C. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
March 08, 2000 | Complete Home Care Equipment Inc. | Nashville District Office | Medical Oxygen | N/A * |
March 07, 2000 | Johnson Matthey Inc. | New Jersey District Office | CGMP/Active Pharmaceutical Ingredients | N/A * |
March 07, 2000 | Walton Medical Center | Atlanta District Office | Mammography Standards | N/A * |
March 07, 2000 | Med Cross Imaging Center | Atlanta District Office | Mammography Standards | N/A * |
March 07, 2000 | Med-Scan - Flint | Detroit District Office | Mammography Standards | N/A * |
March 06, 2000 | IMI of Miami | Florida District Office | Mammography Standards | N/A * |
March 06, 2000 | Early Detection Project Mobile Van Number 2 | Florida District Office | Mammography Standards | N/A * |
March 06, 2000 | Superior Seafood Inc. | Detroit District Office | Seafood Processing Regulations/HACCP | N/A * |
March 06, 2000 | Gourm-E-Co Imports | New York District Office | Imported Cheese/Not Held for Inspection | N/A * |
March 06, 2000 | Landauer Hospital Supplies Inc. | New York District Office | Medical Oxygen | N/A * |
March 06, 2000 | Peachtree City Gynecology Center | Atlanta District Office | Mammography Standards | N/A * |
March 06, 2000 | Riverside Imaging Center | Florida District Office | Mammography Standards | N/A * |
March 06, 2000 | Watson Clinic - Diagnostic Breast Center | Florida District Office | Mammography Standards | N/A * |
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