FDA Action | FDA Recall

Background
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Service that works for you

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

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In order to satisfy the requirements of the FDA, manufacturers must complete product recalls and field corrections in a timely manner. We know you must also provide clear, concise, and accurate documentation. EMSAR’s system and technology ensures that you meet this requirement. Our platform serves as a central repository for all documents and details related to each service call performed.

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.

Our Solution:
  • Recall notification letter process
  • Recall plan development
  • Recall field & bench execution
  • Scheduling
  • Hardware
  • Software
  • Labels
  • Removal & Destruction
  • FDA initial communication
  • Unit Affected List (UAL)
  • Parts logistics

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