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1999 Warning Letters

Warning Letters for 1999

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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

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 30, 1999 Universal Packaging Systems Inc. Los Angeles District Office CGMP/Finished Pharmaceuticals N/A *
December 30, 1999 Breger Vision Center for Devices and Radiological Health Contact Lenses/Lacks Premarket Approval/Misbranded N/A *
December 30, 1999 Raphah Inc. New Jersey District Office Food Labeling N/A *
December 30, 1999 Medical Developmental Research Inc. Center for Devices and Radiological Health Sponsor/Monitor/Contract Research Organization N/A *
December 29, 1999 N. V. N. Inc. New Jersey District Office Seafood Processing Regulations/HACCP N/A *
December 27, 1999 Paynesville Area Health Care System Minneapolis District Office Mammography Standards N/A *
December 27, 1999 TUCO Innovations Inc. Center for Devices and Radiological Health Laser Therapy Devices N/A *
December 27, 1999 ConAgra Inc. Kansas City District Office Medicated Feeds/CGMP N/A *
December 23, 1999 Genetics Institute Center for Biologics Evaluation and Research CGMP Deviations N/A *
December 23, 1999 Tower Rubber Industries Sdn Bhd Center for Devices and Radiological Health Quality System Regulation/Patient Examination Gloves N/A *
December 23, 1999 Miller's Homecare Services New Jersey District Office Oxygen Repackaging Facility N/A *
December 23, 1999 Fantis Foods Inc. New Jersey District Office Seafood Processing Regulations/HACCP N/A *
December 23, 1999 Alliance Medical Corporation Florida District Office Quality System Regulation/Medical Devices Processing N/A *
December 23, 1999 Diasorin s.r.l. Center for Biologics Evaluation and Research Quality System Regulation N/A *
December 22, 1999 Coulston Foundation Center for Drug Evaluation and Research GLP (Good Laboratory Practices) N/A *
December 22, 1999 Associates of Cape Cod Inc. Center for Biologics Evaluation and Research Quality System Regulation/Biologics Listing etc. N/A *
December 22, 1999 Salmolux Inc. Seattle District Office Seafood Processing Regulations/HACCP N/A *
December 22, 1999 Entrees Inc. Seattle District Office Seafood Processing Regulations/HACCP N/A *
December 22, 1999 D and M Dairy San Francisco District Office Food/Cattle N/A *
December 22, 1999 Amelia Springs Water Inc. Baltimore District Office Bottle Water Operation N/A *
December 21, 1999 Progressive Dairy #1 San Francisco District Office Food/Cattle N/A *
December 21, 1999 Fabrica de Flanes Acevedo San Juan District Office Food Labeling N/A *
December 21, 1999 Northwest Airlines New York District Office PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations N/A *
December 21, 1999 Mountain Products Inc. New York District Office Seafood Processing Regulations/HACCP N/A *
December 20, 1999 Danmar Product Inc. Center for Devices and Radiological Health Medical Devices / Premarket Approval Application [PMA] N/A *
December 20, 1999 Disetronic Medical Systems Inc. Minneapolis District Office Quality System Regulation/Infusion Pumps N/A *
December 20, 1999 Westfield Memorial Hospital Buffalo District Office Mammography Standards N/A *
December 20, 1999 Cooksey James R. Cincinnati District Office Food/Cattle N/A *
December 20, 1999 Shared Medical Technology Minneapolis District Office Mammography Standards N/A *
December 20, 1999 Bassett Healthcare New York District Office Mammography Standards N/A *
December 20, 1999 Capt. Vince Inc. New England District Office Seafood Processing Regulations/HACCP N/A *
December 20, 1999 Staten Island University Hospital New York District Office Blood & Blood Components N/A *
December 20, 1999 H. B. Gordon manufacturing Co. Inc. Los Angeles District Office Finished Pharmaceuticals N/A *
December 20, 1999 Thatcher Company Denver District Office Active Pharmaceutical Ingredient N/A *
December 17, 1999 Health Care Solutions Inc. Detroit District Office Medical Oxygen / CGMP N/A *
December 17, 1999 Ortho Clinical Diagnostics Americas Los Angeles District Office Laser Therapy Device/Lacks Premarket Approval/Misbranding/Mislabeling N/A *
December 17, 1999 Baton Rouge Clinic AMC New Orleans District Office Mammography Standards N/A *
December 17, 1999 Rynsburger Dairy San Francisco District Office Food/Cattle N/A *
December 17, 1999 Thames Pharmacal Co. Inc. New York District Office Finished Pharmaceuticals N/A *
December 17, 1999 Hoffmann-LaRoche Inc. New Jersey District Office CGMP/Finished Pharmaceuticals N/A *
December 16, 1999 Amanda Animal Hospital Cincinnati District Office Food/Cattle N/A *
December 16, 1999 Gourmet Award Foods SE Florida District Office Food/Hearts of Palm N/A *
December 15, 1999 International Sterilization Laboratory Corporation Florida District Office Quality System Regulation/Medical Devices Contract Sterilization N/A *
December 15, 1999 Basha Diagnostics P.C. Detroit District Office Mammography Standards N/A *
December 14, 1999 Bladen County Hospital Atlanta District Office Mammography Standards N/A *
December 14, 1999 Addison Gilbert Hospital New England District Office Mammography Standards N/A *
December 14, 1999 Evergrade Healthcare Products SDN. BHD Center for Devices and Radiological Health Quality System Regulation/Examination Gloves N/A *
December 14, 1999 Radiology & Imagaing Inc. New England District Office Mammography Standards N/A *
December 14, 1999 Metrolina Women's Breast Center Atlanta District Office Mammography Standards N/A *
December 14, 1999 American Eagle Airlines Inc. Minneapolis District Office Control of Communicable Disease and Interstate Conveyance Sanitation N/A *
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