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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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1998 Warning Letters

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Warning Letters for 1998

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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
July 08, 1998 Doctors Park Network Chicago District Office Mammography Standards N/A *
July 08, 1998 Steris Corporation Cincinnati District Office Quality System Regulations / Medical Devices N/A *
July 07, 1998 Dermaron Corp. New England District Office New Drug Application N/A *
July 07, 1998 Option Care Home Medical Equipment Dallas District Office Medical Oxygen N/A *
July 07, 1998 Willis Amos M.D. Center for Devices and Radiological Health Clinical Investigator N/A *
July 07, 1998 Llano Memorial Healthcare System Dallas District Office Mammography Standards N/A *
July 07, 1998 Stille Beta Inc. Cincinnati District Office Quality System Regulations / Medical Devices N/A *
July 07, 1998 Baxter Healthcare Corporation New Orleans District Office Deviation from Good Manufacturing Practice / Medical Devices N/A *
July 02, 1998 Hollister Inc. Baltimore District Office Medical Device / Body Fluid Pouch N/A *
July 01, 1998 Rain Forest Pharmaceuticals Inc. Florida District Office New Drug Application N/A *
July 01, 1998 Hato Rey Community Hospital San Juan District Office Mammography Standards N/A *
June 30, 1998 Nature's Acres Minneapolis District Office Labeling N/A *
June 29, 1998 Calhoun Treatment Center Inc. Nashville District Office Narcotics Treatment Program Standards N/A *
June 29, 1998 Schering-Plough Products Inc. San Juan District Office Drug Products / CGMP N/A *
June 26, 1998 2-2-0 Laboratories Los Angeles District Office Over the Counter Drug Products N/A *
June 26, 1998 First Lafayette Holding Company Cincinnati District Office Medical Devices N/A *
June 26, 1998 Novasonics Inc. New York District Office Esophageal Probes N/A *
June 26, 1998 Kingston Hospital Buffalo District Office Mammography Standards N/A *
June 25, 1998 Westlake Laboratories Inc. Cincinnati District Office New Drug Application N/A *
June 25, 1998 Tarmac Products Inc. Florida District Office Prescription Drug Products N/A *



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ICECI Warning Letters

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