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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