Inspections, Compliance, Enforcement, and Criminal Investigations
2001 Warning Letters
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Warning Letters for 2001
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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 |
---|---|---|---|---|
February 20, 2001 | Bryan Enterprises | Cincinnati District Office | Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated | N/A * |
February 16, 2001 | Sidney Hillman Medical Center | Philadelphia District Office | Mammography Quality Standards | N/A * |
February 15, 2001 | Micro Worldwide Trading | Florida District Office | Animal Antibiotic/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
February 15, 2001 | Lubar Seafood Corporation | Florida District Office | Marlin Loins Shipment/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
February 15, 2001 | Greensward Nurseries | San Francisco District Office | Insanitary Conditions/Raw Sprouts/Adulterated | N/A * |
February 15, 2001 | J-Lloyd Medical Inc. | New Jersey District Office | Quality System Regulation/Cardiac Balloon-Catheters/Adulterated | N/A * |
February 15, 2001 | Gulf City Seafoods Inc. | New Orleans District Office | Seafood Processing Regulations/HACCP | N/A * |
February 15, 2001 | Felix Custom Smoking | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
February 15, 2001 | Dakota Clinic Ltd. | Minneapolis District Office | Mammography Standards | N/A * |
February 14, 2001 | Reynolds Health Center | Atlanta District Office | Mammography Standards | N/A * |
February 14, 2001 | Long Island Radiology Associates P. C. | New York District Office | Mammography Standards | N/A * |
February 13, 2001 | Cryogenic Medical Gases | Denver District Office | Medical Oxygen/Adulterated | N/A * |
February 13, 2001 | Schwan's Sales Enterprises Manufacturing Inc. | Dallas District Office | Seafood Processing Regulations/HACCP | N/A * |
February 13, 2001 | Missouri Baptist Medical Center-Mobile | Dallas District Office | Mammography Standards | N/A * |
February 12, 2001 | Howard County General Hospital | Baltimore District Office | Mammography Standards | N/A * |
February 12, 2001 | Nubenco Enterprises Inc. | New Jersey District Office | HIV 1 + 2 Test Kits/Lacks Premarket Approval/Export Regulations/Listing Requirements/Adulterated | N/A * |
February 12, 2001 | Long Island Jewish Radiology Private Practice | New York District Office | Mammography Standards | N/A * |
February 12, 2001 | Beranbaum Khilnani Neistadt Jacobs Hertz & Sherman MDs P.C. | New York District Office | Mammography Standards | N/A * |
February 12, 2001 | Women Care | Minneapolis District Office | Mammography Standards | N/A * |
February 12, 2001 | Continental Airlines | Baltimore District Office | Interstate Conveyance Sanitation Regulations | N/A * |
February 12, 2001 | Gel Spice Company Inc. | New York District Office | Brazilian Black Pepper/Not Held Intact | N/A * |
February 12, 2001 | Beloit Memorial Hospital | Minneapolis District Office | Mammography Standards | N/A * |
February 12, 2001 | UW Health/West Clinic | Minneapolis District Office | Mammography Standards | N/A * |
February 12, 2001 | Basik Swift & Determined | Cincinnati District Office | Veterinary Syringes/Not Held Intact for Inspection/Import | N/A * |
February 12, 2001 | Bioray Inc. | Center for Devices and Radiological Health | Lacks Premarket Approval/Not Substantially Equivalent/Misbranded/Adulterated | N/A * |
February 12, 2001 | Log Haven Dairy | San Francisco District Office | Food/Cattle/Adulterated | N/A * |
February 12, 2001 | Frank Chaves & Sons Dairy | San Francisco District Office | Food/Cattle/Adulterated | N/A * |
February 12, 2001 | Carlos Seafood Incorporated | Florida District Office | Seafood Processing Regulations/HACCP | N/A * |
February 12, 2001 | Optilux | Florida District Office | Contact Lenses/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
February 12, 2001 | University of Kansas | Dallas District Office | Mammography Standards | N/A * |
February 09, 2001 | CoPharma Inc. | Office of Enforcement | GMP of Manufacturing of Bulk Products/Adulterated | N/A * |
February 09, 2001 | Perstrop Specialty Chemicals AB | Center for Devices and Radiological Health | Quality System Regulation/Gels Pads & Powders with Iodine/Adulterated | N/A * |
February 09, 2001 | Medical Diagnostic Imaging | Detroit District Office | Mammography Standards | N/A * |
February 09, 2001 | Ferraris Medical Ltd. | Center for Devices and Radiological Health | Quality System Regulation/Respirometers and Peak Flow Meters/Adulterated | N/A * |
February 09, 2001 | Kingman Regional Medical Center | Los Angeles District Office | Unlicensed Blood Band & Transfusion Service/Adulterated | N/A * |
February 09, 2001 | Lifesigns Inc. | New Orleans District Office | Mammography Standards | N/A * |
February 09, 2001 | Merck & Co. Inc. | Office of Enforcement | GMP for Finished Pharmaceuticals/Biologics Licensing | N/A * |
February 09, 2001 | Curtin Dairy LP | New York District Office | Food/Cattle/Adulterated | N/A * |
February 08, 2001 | Cangene Corporation | Center for Biologics Evaluation and Research | GMP for Finished Products/Biologics/Establishment Licensing | N/A * |
February 08, 2001 | LifeSource Blood Services | Chicago District Office | Good Manufacturing Practice Regulations for Blood and Blood Components | N/A * |
February 07, 2001 | Royal Farms Dairy LLC | Kansas City District Office | Food/Cattle/Adulterated | N/A * |
February 07, 2001 | Boyd-Bluford Inc. | Baltimore District Office | Insanitary Conditions/Food Storage Warehouse/Adulterated | N/A * |
February 07, 2001 | Docheff Dairy | Denver District Office | Dairy/Adulterated/Illegal Drug Residue | N/A * |
February 06, 2001 | Jeby Enterprises | Florida District Office | Carbonated Beverages/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
February 06, 2001 | Vandyk Dairy | Seattle District Office | New Animal Drug/Adulterated | N/A * |
February 06, 2001 | Craig Hessenius Farm | Chicago District Office | Food/Cattle/Adulterated | N/A * |
February 06, 2001 | Jonal Bakery LTD | Chicago District Office | Numerous Insanitary Conditions | N/A * |
February 06, 2001 | Hummermeier Farm | Chicago District Office | Food/Cattle/Adulterated | N/A * |
February 06, 2001 | Donley Farms Inc. | Seattle District Office | New Animal Drug/Adulterated | N/A * |
February 05, 2001 | Cornerstone Dairy | San Francisco District Office | Food/Cattle/Adulterated | N/A * |
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