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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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1999 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters for 1999

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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

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
April 29, 1999 B. Braun Medical Inc. [ARCHIVED] Dallas District Office Infusion Pumps/Quality Systems Regulation N/A *
April 29, 1999 Caribe Food Corporation [ARCHIVED] Florida District Office Shipment Documentation/Bananas N/A *
April 28, 1999 BOC Group Inc. [ARCHIVED] Cincinnati District Office Medical Oxygen N/A *
April 28, 1999 Fairbanks Memorial Hopital [ARCHIVED] Seattle District Office Data Management System N/A *
April 28, 1999 Presidents Specialty Health Care [ARCHIVED] Minneapolis District Office CFR Deviations N/A *
April 28, 1999 PWA Industries SDN BHD [ARCHIVED] Center for Devices and Radiological Health Quality System Regulations/Device Shipment N/A *
April 28, 1999 Cordis Corporation [ARCHIVED] Center for Devices and Radiological Health Devices/Cordis' S.M.A.R.T. Stent N/A *
April 27, 1999 Charles River Endosafe Inc. [ARCHIVED] Center for Biologics Evaluation and Research CFR Deviations N/A *
April 27, 1999 Aspen Medical Clinic [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
April 27, 1999 Cook County North shore Hospital [ARCHIVED] Minneapolis District Office Mammography Standards N/A *
April 27, 1999 Diagnostic Imaging - Mercy Medical Plaza [ARCHIVED] San Francisco District Office Mammography Standards N/A *
April 27, 1999 NVE Inc. [ARCHIVED] New Jersey District Office Content Uniformity Testing/Good Manufacturing Practices N/A *
April 26, 1999 General Therapeutics Corporation [ARCHIVED] Kansas City District Office Drug Products/Standard Operating Procedures (SOP) N/A *
April 26, 1999 Health Science Laboratories and Services Inc. [ARCHIVED] New Jersey District Office Good Manufacturing Practices Violations N/A *
April 26, 1999 Seatrace Pharmaceuticals Inc. [ARCHIVED] Nashville District Office Good Manufacturing Practices Violations N/A *
April 26, 1999 Oratec Interventions Incorporated [ARCHIVED] Center for Devices and Radiological Health Devices/SpineCATH Electorthermal Arthroscopy System N/A *
April 26, 1999 Red Oak Industrial Gas Inc. [ARCHIVED] Kansas City District Office Medical Oxygen N/A *
April 26, 1999 Oconee Medical Inc. [ARCHIVED] Atlanta District Office Medical Oxygen N/A *
April 23, 1999 Bausch & Lomb Incorporated [ARCHIVED] Center for Devices and Radiological Health Devices/Contact Lenses N/A *
April 23, 1999 Ortho-Tain Incorporation [ARCHIVED] Center for Devices and Radiological Health Devices/Dental Instruments N/A *



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ICECI Warning Letters

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