FDA Action | FDA Recall

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Facing an FDA Recall? Here are 5 Ways EMSAR Can help.

FDA product recalls impact hundreds of manufacturers every year and can cause devastating effects on a manufacturer’s finances and reputation. It is imperative to have the adequate resources, expertise, and systems in place to avoid irreversible brand damage and revenue loss.

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EMSAR technicians ensure that work is completed correctly and consistently. Should the need arise, your professional client liaison will work with you to develop a program that meets your financial and scheduling requirements. You can rest assured that we will complete your project on time and on budget.

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EMSAR is experienced in helping companies mitigate risk when facing an FDA Recall. Here’s five ways EMSAR can help your company in this situation:

  1. Planning & Consulting:
    • Assistance with preparing a recall execution plan that includes managing teams, finding execution gaps, and determining the most cost-effective and efficient execution strategy.
    • Training on current regulatory issues, trends, and techniques to promote planning collaboration.
  2. Centralized Recall Project Management
    • 24/7 Call Center staffed with experienced recall professionals to answer questions, address recall concerns, and schedule/ allocate recall execution resources.
    • Product processing to manage recalled products at a secure, quality-control-driven storage facility.
    • Resolution management by delivering product correction or product replacement.
  3. Compliance & Regulatory Reporting 
    • Our validated Service Management System provides proper notification, tracking, processing, data management, recall execution activities, and all other reporting for all required elements of a recall.
  4. Recall Execution
    • On-site product updates and upgrades
    • Depot facility updates, upgrades and product exchanges
    • Product removal, processing, and storage in our secure storage facilities
    • Product end-user training
    • Product configuration and testing
  5. FDA Action Remediation
    • Develop a remediation plan focused on identifying root cause issues and putting solutions in place to avoid future recalls.
    • Continue to assist with the written communication and interactions with the regulatory agencies until all issues are resolved.

Depend On Us.

Contact Info

Ohio Headquarters:
270 Davids Drive
Wilmington, OH 45177
Phone: 800-733-6727
Info@emsar.com

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Austin Headquarters:
9208 Waterford Center Blvd, Suite 150
Austin, TX 78758
Phone: 877-228-6533