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FDA consent decree success story


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A success story of client who received a FDA consent decree and survived. For more information on Consent Decree go to

A success story of client who received a FDA consent decree and survived. For more information on Consent Decree go to

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  • 1. Consent Decree Success StoryA Journey Through A Terrible EventSUCCESSNext Exit
  • 2. What is a consent decree?• A consent decree is an order issued by ajudge that expresses a voluntaryagreement by the participants in alawsuit.• Sometimes a suit ends when a judgeissues a consent decree, or a consentjudgment.• This is especially the case when thedecree is issued after one side of thecase voluntarily agrees to cease aparticular action without admitting toany illegality of the action.
  • 3. Above all else, a CD is…
  • 4. Our story begins…Compliance Insight was not there when the FDA performedthe audit…• Large Midwestern pharmaceutical firm.• Had various issues with some of their tablets – recallsdue to serious defects!• FDA spent some time at the site with a lot of inspectors• 483 and then went straight to Consent Decree!• Firm shut down operations• Various people were fired• Chaos started…
  • 5. We were called ….• Served as QA Plant Manager• Oversight for CD activitiesfor the firm• General compliance help
  • 6. What we did to help!• Our team provided oversight for companydirectives to evaluate and remediate allprocedures• Conducted investigations• Remediated hundreds of CAPA items and openinvestigations• Evaluated processes and provided feedback onhow to remediate them• Worked with all levels of the company toremediate the issues• Dealt with the FDA during audits• It was a long, long struggle – three years!!
  • 7. Our goal was to make thecompany successful again…• We put in great efforts to movethe company forward intocompliance• We have references if you wish tospeak to people on how weperformed…• The first product to go back on themarket after the CD was the onewith oversight from ComplianceInsight!!
  • 8. Top 10 Tips for Dealing witha Consent Decree#1: Understand that you are probably going tobe asked to contract with an expert third party.Carefully select that third party!! They will beyour biggest ally or your worst nightmare. Justbecause the consulting firm promises you theworld, does not mean that they can deliver uponit. Select people with hands-on complianceexperience – in Operations, in the QC Lab, in theWarehouse, etc. Theory is great but will take youonly so far when serious questions are askedregarding how to move forward and actualexperience on the subject matter is needed.
  • 9. Top 10 Tips for Dealing witha Consent Decree#2: You have to be ready for a serious situationand know that things will not be better – for along, long time. This statement is targeted tosenior management and specifically relates to tip#1 above. There are no easy ways out; noamount of “knowing the FDA” will prepare youfor the wrath of putting the FDA into a position toseeking a Consent.#3: Have a close circle of experts and staff thatwill be willing to support the upcoming storm.You may have a cast of thousands that want tohelp. Limit the inner circle to those who canmake decisions and follow through on the actionsneeded.
  • 10. Top 10 Tips for Dealing witha Consent Decree#4: Have open communication to the employees.As best you can perform the task, keep the linesof communication open. People will be worried– and rightly so. If there will be a reduction inforce, determine who and when – do this actionquickly. By the way – you may want to considercommunications with the outside world as well.Your clients (and competition) will quickly pick upon the fact that something serious has happened(or you can preempt the news by notifying thembeforehand).
  • 11. Top 10 Tips for Dealing witha Consent Decree#5: Be ready to resolve the issues and also knowthat you may find more – sometimes, many moreissues that have to be resolved. Getting to aconsent decree usually takes some doing. Youare now under a microscope – anything andeverything that you do will be viewed with an eyeon compliance.#6: Disruptions in your production schedule willhappen. Be prepared. Speak to your customers.Do you have stock that can be shipped? What isthe overall impact to all materials? Do you haveto recall the material?
  • 12. Top 10 Tips for Dealing witha Consent Decree#7: Be prepared for some serious training. Nothe everyday procedural training or annual GMPtraining. We are meaning the “change youropinion”, earth shattering – better know it well!!– type of training. And this training is foreveryone!! Not just the operators or QA – themost senior management at the company/siteMUST be involved with training.#8: Get feedback. Establish a Quality Counciland know what data you must have tounderstand the progress being made. We haveseen good and terrible Quality Council meetings– long, boring, meaningless numbers and chartsor to the point reviews of critical parameters andproject timelines.
  • 13. Top 10 Tips for Dealing witha Consent Decree#9: Visit with the FDA. You are in a very badsituation. All of your credibility has beentrashed!! Establish standard meeting times withyour district to review your progress. Be open,honest and forthcoming.#10: Have a procedure on dealing with theproject. Yes – you heard it! A project! TheConsent Decree will be a big project – lastingover several years. As an example, we’veincluded our internal procedure for you toreview.
  • 14. When we left…the firm was on its way to success
  • 15. We have the answers and solutionsCall us at 513-860-3512
  • 16. Questions? More Information?Compliance Insight, Inc.Call us at513-860-3512Email us