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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