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 |
---|---|---|---|---|
June 02, 2000 | Lyle's Seafoods | Seattle District Office | Seafood Processing Regulations/HACCP | N/A * |
June 02, 2000 | Spanish Gardens Food Mfg. Inc. | Kansas City District Office | Insanitary Conditions | N/A * |
June 02, 2000 | First & Sullivan Radiology Center | Los Angeles District Office | Mammography Standards | N/A * |
June 01, 2000 | Columbia Basin Hospital | Seattle District Office | Mammography Standards | N/A * |
May 31, 2000 | Union City Diagnostic Center | New Jersey District Office | Mammography Standards | N/A * |
May 31, 2000 | Intersurgical Limited | Center for Devices and Radiological Health | Quality System Regulation/Class II Medical Devices | N/A * |
May 31, 2000 | Northeastern Regional Hospital | Dallas District Office | Mammography Standards | N/A * |
May 31, 2000 | Accupac Inc. | Philadelphia District Office | CGMP/Finished Pharmaceuticals | N/A * |
May 30, 2000 | Caribbean Imaging & Radiation Treatment Center | San Juan District Office | Mammography Standards | N/A * |
May 30, 2000 | Barrie House Coffee Co. Inc. | New York District Office | Airline Catering Facility | N/A * |
May 30, 2000 | Golden Neo-Life Diamite International Inc. | San Francisco District Office | Dietary Supplements/Labeling/Misbranded | N/A * |
May 30, 2000 | Chavez Greman M.D. and Bermudez Gamalier M.D. | San Juan District Office | Mammography Standards | N/A * |
May 30, 2000 | Agropharma Laboratories, Inc. | San Juan District Office | CGMP for Finished Pharmaceuticals/OTC Drug & Dietary Supplement/Adulterated | N/A * |
May 26, 2000 | Cleveland Community Hospital | Nashville District Office | Mammography Standards | N/A * |
May 26, 2000 | Foster Poultry Farms | San Francisco District Office | Medicated Feeds/CGMP | N/A * |
May 25, 2000 | Apothecary Products Inc. | Minneapolis District Office | CGMP/Finished Pharmaceuticals | N/A * |
May 24, 2000 | Castleton Family Physicians | Detroit District Office | Mammography Standards | N/A * |
May 24, 2000 | APS (USA) Ltd. | Center for Devices and Radiological Health | Action Potential Stimulation Therapy Device/Promotional Claims/Lacks Premarket Approval/Misbranded | N/A * |
May 24, 2000 | Optoelectronics Technology Co. Ltd. | Center for Devices and Radiological Health | Federal Performance Standard for Laser Products/GLP Green Laser Pointer | N/A * |
May 24, 2000 | Women's Health Care Group P.C. | New Jersey District Office | Mammography Standards | N/A * |
May 24, 2000 | Del Monte Fresh Produce Inc. | New Jersey District Office | Potable Water Hydrants/Backflow Prevention Devices/Violations | N/A * |
May 24, 2000 | Casix in USA | Center for Devices and Radiological Health | Federal Performance Standard for Laser Products | N/A * |
May 24, 2000 | Cummins Howard S. Ph.D. | Center for Drug Evaluation and Research | Clinical Investigator | N/A * |
May 24, 2000 | Biomatrix Incorporated | Center for Devices and Radiological Health | Hylasine Gel/Promotional Material/Lacks Approved Application for Premarket Approval/Misbranded | N/A * |
May 24, 2000 | Macek Anne L. M.D. | Center for Drug Evaluation and Research | Clinical Investigator | N/A * |
May 24, 2000 | Medtronic Inc. | Center for Devices and Radiological Health | Sponsor/Monitor/Contract Research Organization | N/A * |
May 23, 2000 | CIBA Vision Corporation | San Juan District Office | Good Manufacturing Practice Regulaitons for Finished Pharmaceutical/Ophthalmic Drug Products | N/A * |
May 22, 2000 | I.S.P. Company Inc. | Baltimore District Office | Unapproved New Drug Human Animal/GMP/Adulterated/Misbranded | N/A * |
May 22, 2000 | George Washington University Hospital | Baltimore District Office | Mammography Standards | N/A * |
May 22, 2000 | International Medication Systems Limited | Los Angeles District Office | CGMP/Finished Pharmaceuticals | N/A * |
May 22, 2000 | Polynesian Natural Health Products LLC | Los Angeles District Office | Pol'Noni/Promotional Claims/Labeling/Lacks Approved New Drug Application/Misbranded | N/A * |
May 22, 2000 | Templeton Feed and Grain | Los Angeles District Office | Medicated Feed Manufacturing Facility | N/A * |
May 22, 2000 | Price's Power International Inc. | Baltimore District Office | Predator Chromium Picolinate & Power Plus Natural Phen-Fen/Lacks New Drug Application/Therapeutic Cl | N/A * |
May 22, 2000 | Miter Inc. | Detroit District Office | Failure to Comply with Device Quality System Regulation | N/A * |
May 19, 2000 | Phazx Systems Inc. | Center for Devices and Radiological Health | Body Scan 2010 VLD-100/Promotional Material/False and Misleading etc. | N/A * |
May 19, 2000 | West Coast Radiology Center | Los Angeles District Office | Mammography Standards | N/A * |
May 19, 2000 | Fluvanna Correctional Center for Women | Baltimore District Office | Mammography Standards | N/A * |
May 19, 2000 | Americair East Bay | San Francisco District Office | Medical Oxygen / CGMP | N/A * |
May 18, 2000 | Big Shy Farms | Minneapolis District Office | Food/Cattle | N/A * |
May 18, 2000 | Dr. Pepper/Seven Up Inc. | Dallas District Office | Labeling/Misbranded | N/A * |
May 17, 2000 | Sedgwick County Health Center | Dallas District Office | Mammography Standards | N/A * |
May 17, 2000 | Croda Inc. | Florida District Office | Cosmetic Raw Material/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
May 17, 2000 | Othello Community Hospital | Seattle District Office | Mammography Standards | N/A * |
May 17, 2000 | Colorado Plains Medical Center | Dallas District Office | Mammography Standards | N/A * |
May 17, 2000 | Aplicare Inc. | New England District Office | Drug Manufacturing Facilities/CMP Regulations for Finished Pharmaceuticals | N/A * |
May 17, 2000 | UTC International Corporation | Florida District Office | Snapper/Lacks "May Proceed Notice" or "Release Notice" | N/A * |
May 17, 2000 | Baylor-Richardson Medical Center | Dallas District Office | Mammography Standards | N/A * |
May 16, 2000 | L.A.G. Sales Company | New York District Office | Imported Canned Coffee/Entry Not Held Intact | N/A * |
May 16, 2000 | Manchester Veterinary Clinic & Supply P.C. | Detroit District Office | Invalid Veterinarian/Cient/Patient Relationship | N/A * |
May 16, 2000 | John B. Sanfilippo & Son Inc. | Chicago District Office | Imported peanuts/Not Held for Inspection | N/A * |
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