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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

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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
October 06, 1998 Empire Home Medical Inc. San Francisco District Office Medical Oxygen N/A *
October 06, 1998 Gulf Coast Seafood Inc. New Orleans District Office Insanitary Conditions N/A *
October 06, 1998 IntraCel Corporation Center for Biologics Evaluation and Research Sponsor/Monitor/Contract Research Organization N/A *
October 05, 1998 Sysco Corporation Buffalo District Office Seafood Processing Regulations N/A *
October 05, 1998 CGI International LLC Philadelphia District Office Medical Oxygen N/A *
October 05, 1998 North Baldwin Hospital Nashville District Office Mammography Standards N/A *
October 05, 1998 Franklin Hospital Medical Center Center for Drug Evaluation and Research IRB (Institutional Review Board) N/A *
October 05, 1998 Getinge America Chicago District Office Quality System Regulation/Patient Lifts & Hygiene Chairs N/A *
October 05, 1998 Action Industrial Distributor New Jersey District Office Medical Oxygen N/A *
October 02, 1998 G & G Medical and Oxygen New Jersey District Office Medical Oxygen N/A *
October 02, 1998 Haemotronic S.p.a Center for Devices and Radiological Health Devices/Bloodlines N/A *
October 02, 1998 Pharmacia & Upjohn Hillerod A/S Center for Biologics Evaluation and Research CFR Deviations N/A *
October 02, 1998 C & J Seafood and Crab Company Inc. New Orleans District Office Crabmeat Processing N/A *
October 02, 1998 Intermountain Farmers Association Denver District Office CGMP Deviations N/A *
October 01, 1998 Leonard Shrimp Products Incorporated Florida District Office Seafood Processing Regulations/HACCP N/A *
October 01, 1998 Ambulatory Equipment Services New Orleans District Office CGMP Deviations N/A *
October 01, 1998 Smith Norman V.M.D. Philadelphia District Office Food/Cattle N/A *
October 01, 1998 Wind River Herbs Denver District Office Drug Products/Therapeutic Claims N/A *
October 01, 1998 Bausch and Lomb Pharmaceuticals Inc. Florida District Office Drug Products/Manufacture & Distribution Deviations N/A *
October 01, 1998 3H Cattle Company San Francisco District Office Food / Insanitary Conditions N/A *



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ICECI Warning Letters

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