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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

 

Posted on May 26, 2009

Letter Issue Date Company Name Issuing Office Subject Close Out Date
December 18, 1998 Labtician Ophthalmics Center for Devices and Radiological Health Good Manufacturing Practices Violations N/A *
December 18, 1998 American Eagle New York District Office CFR Deviations N/A *
December 18, 1998 SeraCare Acquisitions Inc. Seattle District Office Blood Products N/A *
December 18, 1998 International Medical Inc. Florida District Office Quality System Regulations / Medical Devices N/A *
December 18, 1998 Scottcare Corporation Inc. Cincinnati District Office N/A *
December 18, 1998 Dentek-Lasersystems Produktions Ges.m.b.H. Center for Devices and Radiological Health Laser Product Performance Standard N/A *
December 18, 1998 Evergreen Mills Inc. Dallas District Office Medicated Feeds N/A *
December 18, 1998 Novartis AG Center for Drug Evaluation and Research Postmarketing Adverse Drug Experience N/A *
December 17, 1998 Johnson Donald E. M.D. Center for Drug Evaluation and Research Clinical Investigator N/A *
December 17, 1998 Duesch?r Hilltop Jerseys Minneapolis District Office Food/Cattle N/A *
December 17, 1998 Advanced Vision Research New England District Office Labeling/Eye Drops N/A *
December 16, 1998 Reliv International Inc. Kansas City District Office Drug Products/Labeling N/A *
December 16, 1998 Virjo Seafood Inc. Florida District Office Seafood Processing Regulations/HACCP N/A *
December 16, 1998 Sherwood Brands Inc. New York District Office Federal Food Drug and Cosmetic Act Violations N/A *
December 15, 1998 Catfish Wholesale Inc. New Orleans District Office Food/Sanitation N/A *
December 14, 1998 Boston Electtrodomestici S.r.l. Center for Devices and Radiological Health Laser Products / Noncompliance N/A *
December 14, 1998 Knoll Pharmaceutical Co. New Jersey District Office CGMP/Finished Pharmaceuticals N/A *
December 11, 1998 Diasonics Ultrasound Inc. San Francisco District Office Devices/Ultrasound Probes N/A *
December 11, 1998 Control System Internation Inc. Kansas City District Office Devices/Shotwave Diathermy Device N/A *
December 11, 1998 Schneider's Fish & Seafood Corp. New York District Office Seafood Processing Regulations/HACCP N/A *


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ICECI Warning Letters

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