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 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 *

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