IDEAS home Printed from https://ideas.repec.org/a/ids/ijbcrm/v1y2010i3p259-270.html
   My bibliography  Save this article

Assessing FDA's risk methodology at pharmaceutical manufacturing sites

Author

Listed:
  • Warren Adis

Abstract

This research analyses the US Food and Drug Administration's (FDA's) risk methodology used for inspecting pharmaceutical manufacturing sites. It reviews the procedures, regulations, and violations specified in FDA warning letters (WLs). In particular it focuses on the time period between 2004-2009, as the FDA transitioned and formalised this new approach to site inspections. One of the principal outcomes of this study is to gauge the FDA's performance and assess its new methodology.

Suggested Citation

  • Warren Adis, 2010. "Assessing FDA's risk methodology at pharmaceutical manufacturing sites," International Journal of Business Continuity and Risk Management, Inderscience Enterprises Ltd, vol. 1(3), pages 259-270.
    • Handle: RePEc:ids:ijbcrm:v:1:y:2010:i:3:p:259-270
    as

    Download full text from publisher

    File URL: http://www.inderscience.com/link.php?id=35689
    Download Restriction: Access to full text is restricted to subscribers.
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:ids:ijbcrm:v:1:y:2010:i:3:p:259-270. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Sarah Parker (email available below). General contact details of provider: http://www.inderscience.com/browse/index.php?journalID=333 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.