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 |
---|---|---|---|---|
October 11, 2000 | Sentara Hampton General Hospital | Baltimore District Office | Mammography Standards | N/A * |
October 11, 2000 | Denver Health Medical Center | Dallas District Office | Mammography Standards | N/A * |
October 11, 2000 | Hillsdale Community Health Center | Detroit District Office | Mammography Standards | N/A * |
October 11, 2000 | Nonu Inc. | Denver District Office | New Drug/Labeling/Misbranded | N/A * |
October 11, 2000 | University Hospital Health System and SWGHC | Cincinnati District Office | Mammography Standards | N/A * |
October 11, 2000 | Norland Medical Systems Inc. | Center for Devices and Radiological Health | Orbasone/Lacks Premarket Notification/Labeling/Misbranded | N/A * |
October 10, 2000 | Tasty Foods Place Inc. | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
October 10, 2000 | Mann's Fish Market | Kansas City District Office | Seafood Processing Regulations/HACCP | N/A * |
October 06, 2000 | Gessell Feed Mill Inc. | Minneapolis District Office | Medicated Feeds/CGMP | N/A * |
October 06, 2000 | Heartland Tanning Supplies | Dallas District Office | Federal Performance Standard for Laser Products | N/A * |
October 06, 2000 | Saputo Cheese USA Inc. | Minneapolis District Office | Cheese Products/Raw Milk/Sulfamethazine Contamination | N/A * |
October 06, 2000 | Optima Worldwide Ltd. | Center for Drug Evaluation and Research | GEDA PLUs & SURETE/Lacks New Drug Application/Misbranded | N/A * |
October 06, 2000 | AmeriWater Inc. | Cincinnati District Office | Quality System Regulation/Adultered/Misbranded | N/A * |
October 06, 2000 | ACIPCO Health Services | New Orleans District Office | Mammography Standards | N/A * |
October 06, 2000 | Allina Medical Group | Minneapolis District Office | Mammography Standards | N/A * |
October 06, 2000 | University of Tennessee Medical Center | New Orleans District Office | Eye Bank/Donor Screening Testing/Procedures & Records | N/A * |
October 05, 2000 | H & K Inc. dba Palama Supermarket | San Francisco District Office | Seafood Processing Regulations/HACCP | N/A * |
October 05, 2000 | T & P | Atlanta District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
October 05, 2000 | Manhattan Physician's Group PC | New York District Office | Mammography Standards | N/A * |
October 05, 2000 | Rockaway Open MRI and Diagnostic Imaging | New York District Office | Mammography Standards | N/A * |
October 05, 2000 | Dermatology Surgery and Laser Center | Center for Devices and Radiological Health | Adotomed Silicone/Lacks Premarket Approval/Misbranded/Adulterated | N/A * |
October 05, 2000 | Becker Kenneth B. Sr. | Chicago District Office | Food/Cattle | N/A * |
October 05, 2000 | Soy Shop The | Atlanta District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
October 05, 2000 | Lee's Oriental Food Processors | Atlanta District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
October 04, 2000 | Brigham Radiology Group | New England District Office | Mammography Standards | N/A * |
October 03, 2000 | Wenck Feeds Inc. | Kansas City District Office | Medicated Feeds/CGMP | N/A * |
October 03, 2000 | Palm Bay Community Hospital | Florida District Office | Mammography Standards | N/A * |
October 03, 2000 | Garber Ice Cream Company | Baltimore District Office | Insanitary Conditions | N/A * |
October 02, 2000 | Argus Analytical Inc. | New Orleans District Office | CGMP/Finished Pharmaceuticals | N/A * |
October 02, 2000 | Hospital The | New York District Office | Mammography Standards | N/A * |
September 29, 2000 | Shank Garry B. | Baltimore District Office | Food/Dairy Cow | N/A * |
September 29, 2000 | Firsthealth Family Care Center | Atlanta District Office | Mammography Standards | N/A * |
September 29, 2000 | Empresas Avicolas Colsus Inc. | San Juan District Office | Medicated Feed Manufacturing Facility | N/A * |
September 29, 2000 | Kaiser Permanente - Mountain View | San Francisco District Office | Mammography Standards | N/A * |
September 29, 2000 | Ferris Manufacturing Corporation | Chicago District Office | Ferris Pain Pad & Wrap/Adulterated/Lacks Approved Pre Market Approval Application | N/A * |
September 29, 2000 | New York Medical Group P.C. | New York District Office | Mammography Standards | N/A * |
September 29, 2000 | Lumberton Radiological Associates | Atlanta District Office | Mammography Standards | N/A * |
September 29, 2000 | Health Notification Service | San Francisco District Office | Miracle Wild Yam Cream/Misbranded | N/A * |
September 28, 2000 | Akorn Incorporated | Chicago District Office | Good Manufacturing Practices for Finished Pharmaceuticals | N/A * |
September 28, 2000 | Iron County General Hospital | Detroit District Office | Mammography Standards | N/A * |
September 28, 2000 | Rehoboth Mckinley Christian Hospital | Denver District Office | GMP for Blood & Blood Components/Adulterated | N/A * |
September 28, 2000 | Foxcare Center-Outpatient Testing | New York District Office | Mammography Standards | N/A * |
September 27, 2000 | Roy Lester Schneider Hospital | San Juan District Office | CGMP for Blood & Blood Components/Adulterated | N/A * |
September 27, 2000 | Levenson Jeffrey R. M.D. | Center for Drug Evaluation and Research | Clinical Investigator | N/A * |
September 27, 2000 | Texas Applied Biotechnology Research Review Committee | Center for Devices and Radiological Health | Institutional Review Board | N/A * |
September 27, 2000 | Brenham Clinic | Dallas District Office | Mammography Standards | N/A * |
September 27, 2000 | Fort Worth Imaging Center | Dallas District Office | Mammography Standards | N/A * |
September 27, 2000 | Sun Hing Food Co. Inc. | Chicago District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
September 27, 2000 | Southern Colorado Clinic Mammography Center | Dallas District Office | Mammography Standards | N/A * |
September 26, 2000 | Pine Ridge Reservation Comprehensive Health Center | Minneapolis District Office | Mammography Standards | N/A * |
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