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

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

• 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.