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Case Study: Responding to FDA Orders to Cease Manufacturing

How one client turned a failed FDA inspection into timely remediation with a clear, organized path forward

the situation

The Situation

A reproductive clinic received an Order to Cease Manufacturing following its last FDA inspection. Challenged with the below issues, they contacted EVERSANA asking for assistance in responding to FDA and developing updates for their procedures.

  • Disorganized procedures caused steps in the eligibility determination to be missed
  • Lack of document control organization resulted in the use of different revisions of the same procedure and forms
  • Donor eligibility requirements were not fully understood
the solution

The Solution

  • Created remediation response to FDA’s Order to Cease Manufacturing
  • Within three weeks, created and delivered procedures and forms to provide a fully-compliant Quality Management System
  • Trained physicians and staff on 21 CFR 1271 to instill an understanding of regulatory requirements and the importance of compliance
  • Provided client with a complete response to FDA, including a remediation plan
  • Attended and supported the client during their meetings with FDA to discuss the response and remediation plan
the results

The Results

  • Client resumed a portion of their activities with three months, while FDA reviewed the remainder of the response and remediation plan
  • Implemented clear, organized Document Management System, which allowed for easy expansion of materials and training
  • Greater clinic understanding of regulatory standards through training and its partnership with EVERSANA