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
April 28, 2000	Isner Jeffrey M. M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
April 27, 2000	M Blesy Dairy	Florida District Office	Food/Cattle	N/A *
April 27, 2000	Doctor's Radiology Services	Dallas District Office	Mammography Standards	N/A *
April 26, 2000	Shelhigh Inc.	New Jersey District Office	Quality System Regulation/Uropatch/Medical Device Reporting Regulation	N/A *
April 26, 2000	CCL Custom Manufaturing Inc.	New England District Office	CGMP/Finished Pharmaceuticals	N/A *
April 26, 2000	MRI Institute of Maryland	Baltimore District Office	Mammography Standards	N/A *
April 26, 2000	Arlington Hospital	Baltimore District Office	Mammography Standards	N/A *
April 26, 2000	Med-Pro Inc.	Kansas City District Office	Human Drug Repacking Facility/cGMP	N/A *
April 26, 2000	RFB Latex Limited	Center for Devices and Radiological Health	Quality System Regulation/Examination Gloves	N/A *
April 25, 2000	Northeast Georgia Medical Center Inc.	Center for Biologics Evaluation and Research	IRB (Institutional Review Board)	N/A *
April 25, 2000	Stritzel Farm	Cincinnati District Office	Food/Cattle	N/A *
April 25, 2000	Barranquitas Ultrasound & Mammography Center	San Juan District Office	Mammography Standards	N/A *
April 25, 2000	Humboldt General Hospital	Nashville District Office	Mammography Standards	N/A *
April 25, 2000	Noah's Ark Animal Hospital	New York District Office	Food/Cattle	N/A *
April 24, 2000	Breast Center	Atlanta District Office	Mammography Standards	N/A *
April 24, 2000	North Georgia Medical Center	Atlanta District Office	Mammography Standards	N/A *
April 24, 2000	York Pharmaceutical Inc.	Kansas City District Office	OTC Drug Manufacturing Facility/cGMP	N/A *
April 24, 2000	Albemarle Hospital	Atlanta District Office	Mammography Standards	N/A *
April 21, 2000	Mobile Breast Care Services	Los Angeles District Office	Mammography Standards	N/A *
April 21, 2000	Pacific Coast Tissue Bank	Los Angeles District Office	Tissue Bank/Standard of Operation	N/A *
April 20, 2000	Tripath Imaging Inc.	Center for Devices and Radiological Health	AutoCyte PREP System/Promotional Claims	N/A *
April 20, 2000	Gerben Leyendekker Dairy	San Francisco District Office	Food/Cattle	N/A *
April 19, 2000	Adkinson N. Franklin Jr. M.D.	Center for Biologics Evaluation and Research	Clinical Investigator	N/A *
April 19, 2000	North Colorado Medical Center	Dallas District Office	Mammography Standards	N/A *
April 19, 2000	A & D Healthcare	New Orleans District Office	Medical Oxygen / CGMP	N/A *
April 19, 2000	Genesee Memorial Hospital	New York District Office	Mammography Standards	N/A *
April 19, 2000	Greeley Medical Clinic	Dallas District Office	Mammography Standards	N/A *
April 19, 2000	Parkway Hospital Inc.	Dallas District Office	Mammography Standards	N/A *
April 19, 2000	Seldom Rest Farm	New York District Office	Food/Cattle	N/A *
April 19, 2000	Allergan Inc.	Center for Devices and Radiological Health	AMO PhacoFlex II Intraocular Lens/Promotional Claims/Lacks Application for PMA/Misbranded etc.	N/A *
April 18, 2000	Kubus Inc.	Kansas City District Office	Artificial Insemination Aid/Unapproved New Animal Drug Application	N/A *
April 18, 2000	Mentholatum Co. Inc.	New York District Office	Migraine Ice/Unpproved Application for Premarket Approval	N/A *
April 18, 2000	Microvena Corporation	Minneapolis District Office	Quality System Regulation/Amplatz Thrombectomy Devices	N/A *
April 18, 2000	OmniCorder Technologies Inc.	Center for Devices and Radiological Health	BioScan/Promotional Claims	N/A *
April 18, 2000	Lew-Lin Farms	New York District Office	Food/Cattle	N/A *
April 18, 2000	Kham Seafood	New Orleans District Office	Seafood Processing Regulations/HACCP	N/A *
April 17, 2000	Irasan Complex	Center for Food Safety and Applied Nutrition	Seafood Processing Regulations/HACCP	N/A *
April 17, 2000	Sim-Med Ltd.	Center for Devices and Radiological Health	Laser Product Performance Standard	N/A *
April 17, 2000	Limberg Michael B. M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
April 14, 2000	Stone Mill Foods Inc.	Seattle District Office	Seafood Processing Regulations/HACCP	N/A *
April 14, 2000	Mission Bay Memorial Hospital/Institutional Review Board	Center for Devices and Radiological Health	IRB (Institutional Review Board)	N/A *
April 14, 2000	LaserSight Technologies Inc.	Center for Devices and Radiological Health	LaserScan LSX Excimer Laser/Promotional Claims/Misbranded Etc./Unapproved Use	N/A *
April 14, 2000	Euclid Systems Corporation	Center for Devices and Radiological Health	Sponsor Obligations	N/A *
April 13, 2000	Harper Hospital DMC University Laboratories	Detroit District Office	Blood Bank/CGMP/Finished Pharmaceuticals	N/A *
April 13, 2000	St. Louis Women's Healthcare Group	Dallas District Office	Mammography Standards	N/A *
April 12, 2000	Tri-County Food Services	Cincinnati District Office	Seafood Processing Regulations/HACCP	N/A *
April 12, 2000	Satelec - Amadent	Center for Devices and Radiological Health	Glass Bead Dry Heat Sterilizer/Lacks Premarket Approval	N/A *
April 12, 2000	Euclid Systems Corporation	Baltimore District Office	Quality System Regulation/Contact Lenses	N/A *
April 12, 2000	Avon Hill Farms Inc.	Baltimore District Office	Food/Cattle	N/A *
April 12, 2000	Galveston Medical Supplies Inc.	Dallas District Office	CGMP/Liquid Oxygen/Adulterated	N/A *

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