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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

2009 Warning Letters

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Warning Letters issued in 2009

 

* 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
November 19, 2009 United Fish Distributors, Inc. Detroit District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions March 23, 2011
November 16, 2009 New Horizons LTD Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Med Light Ltd Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Krest Holdings, Panama S.A. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Lorna Hillier Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Petroff, Andrey Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Chris Walsh, c/o Dynadot Privacy Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 BUZZ, LLC Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Hunter, D Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Akyuz, Sinan Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Orion Star & Associates Inc. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Forrest Media Incorporated Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Eugene Lefter Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 William Wynne Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Pro West Marketing Ltd. Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Graham Farms Florida District Office Illegal Drug Residue Not Issued *
November 16, 2009 Randek l-warez Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Chen-Yu Ou Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 tvforever Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *
November 16, 2009 Mendez, Dr Antonio Center for Drug Evaluation and Research Unapproved New Drug/Misbranded Not Issued *



 

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ICECI Warning Letters

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Food and Drug Administration

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