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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2007 Warning Letters

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Tobacco Retailer Warning Letters

 

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Warning Letters for 2007

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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
March 29, 2007 Akorn, Incorporated [ARCHIVED] Chicago District Office CGMP for Finished Pharmaceuticals/Deviations/Adulterated N/A *
March 29, 2007 Chambers, Edward M.D. [ARCHIVED] Center for Biologics Evaluation and Research Clinical Investigator N/A *
March 29, 2007 D.B.I. America Corp [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 29, 2007 Thiele Dairy [ARCHIVED] Kansas City District Office Animal Sale for Slaughter as Food/Adulterated N/A *
March 29, 2007 Freedom Plus Corporation [ARCHIVED] San Francisco District Office Dietary Supplement/Adulterated N/A *
March 28, 2007 Sleep Devices, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 26, 2007 Chi Global Foods System, Inc. [ARCHIVED] San Francisco District Office Seafood HACCP N/A *
March 26, 2007 Rockland Farm [ARCHIVED] New England District Office Illegal Drug Residue N/A *
March 26, 2007 Clearview Dairy, LLC [ARCHIVED] Seattle District Office Illegal Drug Residue N/A *
March 23, 2007 Neotropix, Inc. [ARCHIVED] Center for Biologics Evaluation and Research Good Laboratory Practice (GLP) Regulations N/A *
March 23, 2007 Sigma International General Medical Apparatus, LLC [ARCHIVED] New York District Office CGMP/QSR/Medical Devices/Adulterated N/A *
March 23, 2007 Gloucester Seafood, Inc. [ARCHIVED] Baltimore District Office Seafood HACCP/Adulterated N/A *
March 22, 2007 Access Point Medical LLC [ARCHIVED] Kansas City District Office Federal Food, Drug and Cosmetic Act Violations N/A *
March 22, 2007 Madera Calf Ranch [ARCHIVED] San Francisco District Office Illegal Drug Residue N/A *
March 21, 2007 Bentec Medical, Inc. [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions (Sponsor) N/A *
March 21, 2007 ComputeRx/Broncho-Dose, Ltd. [ARCHIVED] New England District Office Federal Food, Drug and Cosmetic Act Violations N/A *
March 19, 2007 Fairmont Dairy LLC [ARCHIVED] New England District Office Illegal Drug Residue N/A *
March 15, 2007 Nich Marketers Inc. [ARCHIVED] Cincinnati District Office Labeling & Promotional Materials N/A *
March 15, 2007 Stryker Ireland, Ltd., Orthopaedics [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated N/A *
March 14, 2007 KSM, Inc. [ARCHIVED] Center for Devices and Radiological Health Investigational Device Exemptions (Sponsor) N/A *



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ICECI Warning Letters

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Food and Drug Administration

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Rockville, MD 20857
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