3 Elements of an FDA Recall Strategy

James P. Ellison and Anne K. Walsh’s FDA Deskbook: A Compliance and Enforcement Guide provides an in-depth discussion on recalls.

A firm conducting a recall must develop a recall strategy taking into account the results of the Health Hazard Evaluation (HHE), ease in identifying the product, the degree to which the product’s deficiency is obvious to the consumer or user, the degree to which the product remains unused in the marketplace, and the continued availability of essential products. FDA will review and approve the recall strategy of a recalling firm. The elements of a recall strategy are:

  1. Depth of Recall The depth of recall pertains to the level in the distribution chain to which the recall will be extended. This will depend on the product’s degree of hazard and extent of its distribution. For example, the recall could extend all the way to the consumer or user level, it could stop at the retail level, or it may not need to go beyond the wholesale level.
  2. Public Warning A public warning is intended to alert the public that “a product being recalled presents a serious hazard to health.” It is only used in urgent situations for which other means of preventing use of the product appear inadequate. FDA will usually issue the warning in consultation with the recalling firm. If the firm issues its own warning, it should submit the warning to FDA for review and comment prior to distribution, along with a plan for distribution. The recall strategy should indicate whether a public warning is needed and how it will be issued, for example, via general or specialized news media.
  3. Effectiveness Checks Effectiveness checks are required to confirm that all consignees at the specified recall depth received the notification. Consignees may be contacted by whatever means deemed appropriate by the recalling firm, including by letter, telephone calls, or a combination. It is recommended that a firm conduct at least the initial effectiveness check in writing, and may then follow up via telephone if no response is received. When a phone call is made, the firm should document the call and that documentation should be retained in the recall record. The recall strategy will specify the methods to be used and the level of effectiveness checks that will be conducted. Depending on the product involved and the health hazard presented by the product, a firm may be required to contact 100% of consignees, or may not be required to conduct an effectiveness check at all.

 

TO LEARN MORE ABOUT THE FDA, READ:

FDA Deskbook: A Compliance and Enforcement Guide Edited by James P. Ellison and Anne K. Walsh (Hyman, Phelps & McNamara, P.C.)

Subcribe to Discover PLUS?  Read it here — ›

New Answer Book! Privacy Law Answer Book

Privacy Law Answer BookPLI’s new Privacy Law Answer Book answers key questions related to the evolving collection, use, and storage of consumers’ personal information.

The Q&A-formatted guide makes clear sense of the patchwork of federal, state and international laws and regulations, with expert guidance on privacy policies, COPPA, financial privacy, medical privacy, and more.

Edited by Jeremy Feigelson (Debevoise & Plimpton LLP), the Answer Book will help readers keep clients and companies one step ahead of the data privacy challenges of tomorrow.

This essential new title is available on PLI Discover PLUS, our online research database. If you’d like to order a print copy, please email the PLI Library Help Desk or call 877-900-5291.

 

Announcing our $1,000 Orbitz Gift Card Winner!

Congratulations to Dennis Sears, Associate Director for Legal Research Instruction at the Howard H. Hunter Law Library at Brigham Young University, on winning our 2016 AALL raffle. To celebrate our global reach – Discover PLUS is now in all 50 states and more than 65 countries –  we raffled a $1,000 Orbitz gift card at this year’s AALL Annual Meeting and Contest. Bon voyage, Dennis!

We would like to thank everyone who stopped by our booth and entered our raffle.  It was a pleasure meeting and re-connecting with all of you and we hope to see you next year!

 

AALL Librarian Advisory Breakfast Wrap-Up and Raffle Winner!

Many thanks to everyone who came to our Librarian Advisory Breakfast during AALL! We had a full house, great conversation, and delicious food!

2016 AALL Breakfast Room 2

Alexa Robertson (Director of Legal Information Services & Electronic Publishing) reviewed the changes we’ve made to PLI Discover PLUS since last summer’s conference and highlighted the many new titles that are now in our catalog.  Alexa also updated those in attendance on the archive project and showed our enhanced date range filter, which allows you to filter by decade as well as individual year.

Next, Christina Davis (Library Relations Manager) provided a demo of both Discover PLUS and the Discover PLUS app, which showcased our platforms, the ease of use, and our invaluable content.

On to the raffle. In an effort to pay homage to Chicago–known for its deep dish pizza, pierogies, and jibaritos–we raffled off a $150 gift certificate to Open Table. It was a fitting prize since Discover PLUS allows you to bring the experts to your table! Congratulations to Gina Cartusciello of Cahill, Gordon & Reindel, who won!

PLUS Advisory Council

Your feedback is requested!

We at PLI worked closely with the legal research community to develop our online legal research database. Now we have created the PLUS Advisory Council to continue to work with you as the product evolves.

The PLUS Advisory Council is an advisory group of Discover PLUS customer members that provides input to PLI on product direction for the PLUS legal research database. The Council submits and reviews enhancement requests, and determines the validity and value of each request. The Council then makes recommendations to PLI to help with future planning and better prioritize the enhancements made to the PLUS platform.

PLI will communicate primarily through email to accommodate members’ schedules. Participation is voluntary. If you are interested in participating, or would like additional information, please write PLUS@pli.edu.

PLI Discover PLUS Sample Search Video Tutorial – The Panama Papers

PLI Discover PLUS provides expert analysis of ripped-from-the headlines legal issues from today’s leading practitioners.

Here’s a 1.16 minute sample search video tutorial, which illustrates how to search for documents about the Panama Papers. Make sure to check out the rest of our videos on the PLI Librarian YouTube channel!

We will continue to add instructional videos to this channel, so stay tuned for more! And if you have any suggestions on search tips videos you would like to see, please contact the PLUS Help Desk .

Discover PLUS Enhancement – Date Range Filter

Discover PLUS Enhancement – Date Range Filter

We recently made an enhancement to PLI Discover PLUS, which makes it even easier to filter by publication year.  Instead of  just filtering by individual years, you can now filter by decades.  This enhancement recently debuted to accommodate our growing archival collection as we continue to add content back as early as 1980.

Now you can filter results using a 10 year date range on the search results page.

For example, if I want to learn more about how mortgage-backed securities were used in financing from 2000 – 2009, I can do a search for “mortgage-backed securit!” /s financ! and then use the date filters on the search results page to select 2000 – 2009:Date Range Filter

If you have any questions about this enhancement, or you’d like to schedule a quick training session to review, please contact PLI Discover PLUS Help Desk or call 877-900-5291.

What’s New on PLI Discover PLUS for June

06-2016 What's New

We add content to PLI Discover PLUS every month to ensure our subscribers have access to the most up-to-date and relevant secondary source legal documents. Renowned legal experts regularly updated our acclaimed Treatises, Course Handbooks, Answer Books, Transcripts and Forms to reflect recent changes and developments in the law.

Click here to see what we added in June.

New Treatise! A Starter Guide to Doing Business in the United States

Doing Business in the United States

A Starter Guide to Doing Business in the United States is a new “must read” for non-U.S. businesses, foreign attorneys, law firm associates and new entrepreneurs. Edited by Woon-Wah Siu (Pillsbury Winthrop Shaw Pittman LLP) the Starter Guide covers the main legal and regulatory issues to be considered before entering the U.S. market, including:

  • Choice of a business entity—describing the requirements for a corporation, LLC, partnership, and sole proprietorship
  • Federal securities law—discusses the major statutes, provisions and regulations controlling the creation and exchange of business interests; the chapter includes what is required to qualify as a Foreign Private Issuer
  • Buying a company: the M&A process—highlighting each step of the process and the differences between buying a U.S. company and a non-U.S. company
  • Employment considerations—providing general guidance on the issues and statutes that arise when hiring employees in the U.S.
  • Equity incentives for U.S. employees—comparing the permissible types of equity incentives and the related, relevant tax and accounting treatment of such incentives
  • Immigration law—describing the requirements for the various types of employment-related visas and other business-related provisions
  • U.S. international trade law—exploring, in the book’s most extensive chapter, the many major statutes and international agreements that regulate importing into, exporting out of, or investing in the United States
  • Protecting intellectual property—describing the kinds of protections in the U.S. and how to derive maximum value from your IP through licensing, and how to assert or defend your IP in litigation
  • Environmental law—describing the requirements mandated by major federal and state statutes and regulations, as well as providing suggestions on successful compliance strategies
  • Taxation—describing the many kinds of taxes affecting trade and business, and focusing on the distinctions between how U.S. persons versus non-U.S. persons, as well as U.S. source versus non-U.S. source income, are treated
  • Litigation before courts and agencies, mediation and arbitration—providing a general discussion of the structure of the court systems in the United States as applied to civil cases, the terminology and procedure generally used in U.S. courts, enforcement of court judgments, and specialized tribunals, arbitration and mediation.

The Starter Guide also includes concepts in U.S. commercial real estate transactions, regulation of the energy sector, products liability law, and business insurance. This new guide also provides useful charts, tables, best practices and highlighted tips.

This essential new title is available on PLI Discover PLUS, our online research database. If you’d like to order a print copy, please email the PLI Library Help Desk or call 877-900-5291.