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FDA Warning Letters to Sponsors, Monitors, and Contract Research Organizations

Notice: if there has been a substantive change in matters described in FDA warning letters we will gladly update our information. Please use the Webmaster email link at the bottom of this page to contact us.

We post warning letters to clinical investigators, sponsors, and institutional review boards (IRBs) issued by the United States Food and Drug Administration (FDA) on the CIRCARE web site. Prior to mid-2009 we provided links to these documents on the FDA website. We repeatedly corrected hundreds of links but after the FDA website revision in 2009 we decided to post relevant warning letters on our website to conserve resources while keeping these documents in the public eye. Although we make good faith efforts to monitor FDA warning letters we cannot guarantee matters have not changed. Therefore visitors should consult the FDA website for the most current information. The main FDA warning letter webpage is available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Visitors may wish to consult FDA's list of warning letters with closeout letters at: http://tinyurl.com/78k39vu

FDA provides additional information about warning letters at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#moreinfo

From time to time FDA reorganizes its website. Before you contact us to say that FDA "rescinded" your warning letter please use the Warning Letter search on the FDA website: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Please review our Terms of Use for important information about material posted on the CIRCARE web site.

Key to abbreviations and information about FDA administrative actions

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Key
PEDS: one or more studies enrolled children.
SUSP: suspension of institutional review board (IRB) authority to review and approve new research subject to FDA regulations.
CBER: Center for Biologics Evaluation and Research.
CDER: Center for Drug Evaluation and Research.
CDRH: Center for Devices and Radiological Health.

Sources:
FDA Warning Letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
FDA CDER Warning Letters (see explanation at link): http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm
FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters: http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm092185.htm
FDA Notice of Opportunity for Hearing (NOOH) Letters: http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm143240.htm
FDA Presiding Officer Reports and Commissioner's Decisions in Clinical Investigator Disqualifications Proceedings: http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm143242.htm
FDA Debarment List: http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm
Requests under the Freedom of Information Act.

Warning Letter: A Warning Letter is an informal advisory, to a firm or clinical investigator, communicating the Agency's position on a matter but does not commit FDA to taking enforcement action. A Warning Letter is issued for significant regulatory violations that require prompt and adequate corrective actions. FDA Center for Drug Evaluation and Research. Accessed on 2009-06-29 at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm

NIDPOE: A NIDPOE letter informs the recipient clinical investigator that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to the Food and Drug Administration's regulations. Generally, FDA issues a NIDPOE letter when it believes it has evidence that the clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor. FDA Center for Drug Evaluation and Research. Accessed on 2009-06-29 at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm

NOOH: The Notice of Opportunity for Hearing provides an individual with the opportunity for a hearing on a regulatory action, including a proposed action (such as disqualification), before a presiding officer designated by the Commissioner. FDA Center for Drug Evaluation and Research. Accessed on 2009-06-29 at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm


Notes

1. Cavitat Medical Technologies, Inc. and Robert J. Jones vs. Aetna, Inc. Civil No. 04CV01849. Exhibit, Plaintiff's Response to Motion to Bifurcate or, Alternatively, Reset the Trial Date. USDC District of Colorado. 2005-12-28.

2. Source: Marilyn A. Coleman and Ovimmune, Inc. v. Sally W. Wiley et al. Case No. 2002CV0048. Common Pleas Court Union County, OH. Complaint (Exhibit A). 2002-02-21: http://www.circare.org/FOIA/2002cv0048_complaint.pdf


Last Updated: 2014-07-10

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