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Client Success Story

the situation

The Situation

A company was notified that the FDA was going to perform an inspection the following week. They had just undergone a change in ownership, had lost internal resources with experience handling regulatory inspections, and did not have access to a majority of the Quality System policies and procedures as well as Quality Records associated with devices on the market.

the solution

The Solution

EVERSANA deployed a resource within one day to go on site to perform a gap assessment. Upon execution, several additional and critical issues were identified. Our expert:

  • Wrote a Handling Regulatory Inspections SOP and executed a training session for all team members to be involved in the inspection, as well as all members of executive management, on how to handle the upcoming FDA Inspection.
  • Collaboratively worked with the company in order to open multiple CAPAs to address the most significant issues identified during the gap assessment, prior to the arrival of the FDA investigator.
  • Remained on site and managed the FDA inspection with the client.
the results

The Results

  • Company resources felt much more confident in their ability to handle the inspection and interactions with the investigator.
  • Only minor 483 Observations were received.
  • No 483 Observations were associated with the significant issues included within the CAPAs opened just prior to the inspection.