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.
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:
• Confidence in ability to handle inspection and interactions with the investigator.
• Only minor 483 Observations received.
• No 483 Observations associated with the significant issues included within the CAPAs opened just prior to the inspection.