FDA Action | FDA Recall

FDA 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. We execute timely solutions to FDA recalls, developing a program that meets your financial and scheduling requirements.

With our clinical go-live support, EMSAR technicians will upgrade and retrofit any product facing an FDA recall, ensuring work is completed correctly and consistently. Should the need arise, your professional client liaison will work with you to schedule a time to address a field change order or field corrective action.

EMSAR is experienced in helping companies mitigate risk when facing an FDA recall. Here are 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 Clinical Go-Live Support 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, FDA recall execution activities, and all other reporting for all required elements of a recall.
4. Recall Execution
   • Recall execution process includes:
     1. On-site product updates and upgrades/retrofits
     2. Depot facility updates, upgrades, and product exchanges
     3. Product removal, processing, and storage in our secure storage facilities
     4. Product end-user training
     5. 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.

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.

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.

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.