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 |
---|---|---|---|---|
November 16, 2000 | Saad Mayer J. M.D. | New York District Office | Mammography Standards | N/A * |
November 16, 2000 | Ward I.W. | Dallas District Office | Horse Buyer/Dealer/New Animal Drug/Adulterated/Insanitary Conditions | N/A * |
November 16, 2000 | Houston Medical Center | Atlanta District Office | Mammography Standards | N/A * |
November 16, 2000 | Moss Tubes Inc. | New York District Office | Quality System Regulation/Nasal Tubes/Adulterated | N/A * |
November 15, 2000 | Value Frozen Foods Inc. | Dallas District Office | Mustard Greens/Pesticide Chemical Permethrin | N/A * |
November 15, 2000 | NE Medical Center Outreach Health Services-Mobile | Atlanta District Office | Mammography Standards | N/A * |
November 15, 2000 | Carolina Pines Regional Medical Center | Atlanta District Office | Mammography Standards | N/A * |
November 15, 2000 | Cedar County Memorial Hospital | Dallas District Office | Mammography Standards | N/A * |
November 15, 2000 | Comercial San Carlos | Florida District Office | Foodstuffs/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
November 14, 2000 | Mahoi Janet C. | San Francisco District Office | Smoked Fish/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
November 14, 2000 | Brosan Inc. dba Simex Internation | San Francisco District Office | Seafood Processing Regulations/HACCP | N/A * |
November 13, 2000 | Sybron Chemicals Inc. | New Jersey District Office | Good Manufacturing Practices/Active Pharmaceutical Ingredients/Adulterated | N/A * |
November 13, 2000 | Cytosol Laboratories Inc. | New England District Office | Anticoagulant Drug Products/Lacks NDA ANDA IND/Labeling/Device-Adulterated | N/A * |
November 13, 2000 | Vassar Brothers Hospital | New York District Office | Mammography Standards | N/A * |
November 13, 2000 | Precise Biomedical Inc. | Cincinnati District Office | Performance Standard for Diagnosict X-Ray Equipment | N/A * |
November 13, 2000 | Lakewood Regional Medical Center | Los Angeles District Office | Mammography Standards | N/A * |
November 13, 2000 | Bateman Food Distributors | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
November 13, 2000 | San Clemente Hospital | Los Angeles District Office | Mammography Standards | N/A * |
November 13, 2000 | Southern California Radiology | Los Angeles District Office | Mammography Standards | N/A * |
November 13, 2000 | Fairview University Medical Center | Minneapolis District Office | Mammography Standards | N/A * |
November 13, 2000 | Northside Medical Center - Beeghly Medical Park | Cincinnati District Office | Mammography Standards | N/A * |
November 13, 2000 | Ocean Five Incorporated | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
November 13, 2000 | Unique Laboratories Inc. | Atlanta District Office | Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated | N/A * |
November 09, 2000 | Les Trois Petits Conchons | Philadelphia District Office | Seafood Processing Regulations/HACCP | N/A * |
November 09, 2000 | Selby General Hospital | Cincinnati District Office | Mammography Standards | N/A * |
November 09, 2000 | Trumbull Memorial Hospital | Cincinnati District Office | Mammography Standards | N/A * |
November 09, 2000 | Tofu Palace Products | Seattle District Office | Lite & Spicy Tofu Pate/Labeling | N/A * |
November 09, 2000 | SeaCrest Foods Inc. | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
November 09, 2000 | Moreland Dale L. | Chicago District Office | Food/Cattle | N/A * |
November 09, 2000 | Westchester Gynecologists & Obstetricians P. C. | New York District Office | Mammography Standards | N/A * |
November 08, 2000 | Visions in Endosurgery Inc. | Florida District Office | Quality System Regulation/Medical Devices/Adulterated | N/A * |
November 08, 2000 | Rotary Dairy | Seattle District Office | Food/Cattle | N/A * |
November 08, 2000 | Good Samaritan Hospital | Dallas District Office | Mammography Standards | N/A * |
November 08, 2000 | Spectrum Medical Services Inc. | Florida District Office | Mammography Standards | N/A * |
November 08, 2000 | Plitt Company | Chicago District Office | Fresh Alaskan Halibut Shipment/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
November 08, 2000 | Degraff Memorial Hospital | New York District Office | Mammography Standards | N/A * |
November 07, 2000 | Hydrokinetic Contact Lens Laboratory | Dallas District Office | NewView2 Progressive Addition Contact Lenses/Adulterated/Misbranded | N/A * |
November 07, 2000 | North American Medical Products Inc. | New York District Office | Sare-Point Needle Cover/Adulterated/Misbranded | N/A * |
November 06, 2000 | Bryce Clinical Laboratories Inc. | Florida District Office | Testing Laboratory/Human Tissue Intended for Transplantation | N/A * |
November 06, 2000 | Santana Enterprises Inc. | Florida District Office | Vanilla/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
November 06, 2000 | Seattle Fish Company | Denver District Office | Seafood HACCP/Adulterated | N/A * |
November 06, 2000 | Weaverville Family Medicine Associates | Atlanta District Office | Mammography Standards | N/A * |
November 06, 2000 | Snow Peas International Inc. | Florida District Office | Chinese and Indian Eggplant/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
November 03, 2000 | West Hollywood Mammography | Los Angeles District Office | Mammography Standards | N/A * |
November 03, 2000 | Cambridge Medical Center | Minneapolis District Office | Mammography Standards | N/A * |
November 03, 2000 | Aurora Medical Group | Minneapolis District Office | Mammography Standards | N/A * |
November 03, 2000 | McAbee Medical Inc. | New Orleans District Office | Medical Oxygen / CGMP | N/A * |
November 02, 2000 | Banner Mountain Sprouts | San Francisco District Office | CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts | N/A * |
November 02, 2000 | X-Diagnostic Imaging | Los Angeles District Office | Mammography Standards | N/A * |
November 01, 2000 | Sciarra Laboratories Inc. | New York District Office | Good Manufacturing Practices for Finished Pharmaceuticals | N/A * |
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