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
March 03, 2000	Institute for Human Gene Therapy	Center for Biologics Evaluation and Research	Gene Therapy	N/A *
March 03, 2000	St. Louis Medical Clinic	Dallas District Office	Mammography Standards	N/A *
March 03, 2000	Diagnostic Imaging	Dallas District Office	Performance Standards for Diagnostic X-ray Equipment	N/A *
March 02, 2000	Medical Center of Southwest Louisiana	New Orleans District Office	Mammography Standards	N/A *
March 02, 2000	Dickenson County Medical Center	Baltimore District Office	Mammography Standards	N/A *
March 02, 2000	Schein Pharmaceutical Inc.	New Jersey District Office	Finished Pharmaceuticals/Oxygen Repackaging Facility/CGMP	N/A *
March 01, 2000	Essex Institutional Review Board Inc.	Center for Biologics Evaluation and Research	IRB (Institutional Review Board)	N/A *
March 01, 2000	Sands Hyperbaric Systems (SHS)	Center for Devices and Radiological Health	Off-Label Use	N/A *
March 01, 2000	Bon Secours/Cottage Health Services Diagnostic Center	Detroit District Office	Mammography Standards	N/A *
February 29, 2000	Southwest Diagnostic Center Ldt.	Dallas District Office	Mammography Standards	N/A *
February 29, 2000	Cushing Memorial Hospital	Dallas District Office	Mammography Standards	N/A *
February 29, 2000	Memorial Atrium Imaging	New Orleans District Office	Mammography Standards	N/A *
February 29, 2000	Diagnostic Imaging Associates	New York District Office	Mammography Standards	N/A *
February 28, 2000	Allied Industriel Gases LLC	Atlanta District Office	Medical Oxygen / CGMP	N/A *
February 28, 2000	Diagnostic Imaging	Dallas District Office	X-ray Equipment/Performance Standards for Diagnostic Radiation Emitting Products	N/A *
February 28, 2000	Community Memorial Hospital	Cincinnati District Office	Mammography Standards	N/A *
February 28, 2000	Southern Clinic P.A.	Dallas District Office	Mammography Standards	N/A *
February 28, 2000	Eastside Ophthalmology P.C.	Center for Devices and Radiological Health	Phakic Intraocular Lenses/Lacks Premarket Approval/Misbranding	N/A *
February 28, 2000	Diagnostic Imaging	Dallas District Office	X-ray Equipment/Performance Standards for Diagnostic Radiation Emitting Products	N/A *
February 28, 2000	St. Michael Health Care Center	Dallas District Office	Mammography Standards	N/A *
February 25, 2000	Nova-Tech Inc.	Kansas City District Office	Good Manufacturing Practices Violation/Finished Pharmaceuticals	N/A *
February 25, 2000	ERBE Elektromedizin GmbH	Center for Devices and Radiological Health	Electrosurgical Systems/Lack Premarket Norification/Quality System Regulation	N/A *
February 25, 2000	Anderson C. Joseph M.D.	Center for Devices and Radiological Health	Clinical Investigator	N/A *
February 25, 2000	North American Purchase & Trade	Florida District Office	Devices/Not Held for Inspection	N/A *
February 25, 2000	Queen of Peace Hospital	Minneapolis District Office	Mammography Standards	N/A *
February 25, 2000	AvidCare	Minneapolis District Office	Quality System Regulation/Home Health Monitoring Systems	N/A *
February 25, 2000	Chi Thanh Trading Co.	San Francisco District Office	Labeling/Dried Geckoes/Product Misrepresentation	N/A *
February 25, 2000	Appleton Medical Center	Minneapolis District Office	Mammography Standards	N/A *
February 25, 2000	Outpatient Surgery Center for Sight IRB	Center for Devices and Radiological Health	IRB (Institutional Review Board)	N/A *
February 24, 2000	Satilla Health Services Inc.	Atlanta District Office	Medical Oxygen / CGMP	N/A *
February 23, 2000	Nassau County Medical Center	New York District Office	Mammography Standards	N/A *
February 23, 2000	Thomas & Thompson Company Inc.	Baltimore District Office	Drug Products/Topical Salve/Manufacturing Processing Packing Storage or Holding	N/A *
February 22, 2000	St. Joseph Health Care Center	Cincinnati District Office	Mammography Standards	N/A *
February 22, 2000	ETMC - Crockett [FXA: Houston Co. Hospital]	Dallas District Office	Mammography Standards	N/A *
February 22, 2000	All Brazilian Import & Export Inc.	Florida District Office	Imported Food/Not Available for Inspection	N/A *
February 22, 2000	Women's Health Center of South Nassau	New York District Office	Mammography Standards	N/A *
February 22, 2000	Women's Health Services Chattanooga P.C.	New Orleans District Office	Mammography Standards	N/A *
February 22, 2000	Belmont Community Hospital	Cincinnati District Office	Mammography Standards	N/A *
February 22, 2000	Panorama Diagnostic & Imaging	Los Angeles District Office	Mammography Standards	N/A *
February 22, 2000	Universal MRI and Diagnostic Center of Queens New York	New York District Office	Mammography Standards	N/A *
February 22, 2000	Valley Women's Clinic	Dallas District Office	Mammography Standards	N/A *
February 22, 2000	East Texas Medical Center- Carthage	Dallas District Office	Mammography Standards	N/A *
February 22, 2000	Sure-Way Systems Inc.	Los Angeles District Office	Quality System Regulation/Reusable Sharps Containers	N/A *
February 18, 2000	Draper Valley Farms Inc.	Seattle District Office	Medicated Feeds/CGMP	N/A *
February 18, 2000	Hoots Memorial Hospital	Atlanta District Office	Mammography Standards	N/A *
February 18, 2000	Amuchina International Inc.	Baltimore District Office	Medical Device Reporting & Quality System Regulation/Amukin-D	N/A *
February 18, 2000	Port Authority of New York & New Jersey	New York District Office	Vessel Watering Points	N/A *
February 18, 2000	Exclusive Fresh Inc.	San Francisco District Office	Seafood Processing Regulations/HACCP	N/A *
February 17, 2000	Lubar Seafood Corporation	Florida District Office	Seafood Processing Regulations/HACCP	N/A *
February 17, 2000	Sulzer Spine-Tech	Center for Devices and Radiological Health	BAK Interbody Fusion System/Promotional Claims	N/A *

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