FDA Crisis Intervention
Though we hope this never occurs, at times companies do run into situations they were not prepared for, or understand, while dealing with the FDA. We have seen this over and over again with our clients worldwide.
These unexpected situations could be:
A Surprise FDA Inspection Visit
When the FDA gets information on one of your devices, such Such as incorrect labeling, failures, or injuries, and the FDA knocks on your door, understanding what the FDA is looking for, and what information to supply, will make all the difference in how the inspection will turnout.
- Did you know of the problem/complaint?
- Had you properly documented it?
- Did you conduct an investigation, and correctly document it?
- If you didn’t investigate did you document why an investigation was not required?
- Did you make the MDR report to the FDA?
- Did you determine if any additional action was needed?
- Did you do a “risk analysis”?
- Were you required to notify the FDA of this additional action?
The FDA is now inspecting your company concerning an issue. You want to make sure it does not grow into an extensive investigation.
Problems with the actual inspection and investigator
Your involved in a “routine” FDA inspection: you sense your having a problem with the investigator and his/her’s methods or interpretations. You don’t get a chance to explain your side of the situation. The investigator is going off on tangents.
You need to get a handle on the inspection and understand the potential problems resulting from the outcome of this inspection.
You need someone to advocate in your behalf, provide the guidance on how to deal with this “difficult” investigator, or an inspection that appears to be getting out-of-hand.
Special FDA investigation
The FDA conducts an investigation on a class of devices and/or processes.; and, knowing what the FDA is looking for, and how to respond, can be critical to your operations, and devices in the field.
Would you know how to react if an FDA “criminal investigator” turned up at your door?
A 483 or Warning Letter and not knowing how to respond.
- Now the FDA inspection is over and your issued a 483 (the list of observations) or the findings that the investigator made during the inspection. Do you know what to do with it?
- You need to understand what the FDA is expecting in a written response. The proper response can rectify the situation and prevent further regulatory actions – Warning Letter is the next step taken by the FDA.
- When do you request a meeting with the FDA?
- How much time do you have to respond to the FDA 483? Can you request additional time?
- You received an FDA Warning Letter, now what?
- How do you respond?
- How much time do you have to address the FDA concerns?
- Do you need an FDA meeting?
- Make sure you use the right consultants to help deal with these issues.
Preparing for an FDA a meeting
- What are you trying to achieve in this meeting?
- Did the FDA ask or are you asking for the meeting?
- Determining who will be attending the meeting.
- Set up an agenda.
- Determine who will take the lead.
- A consultant should be invited to the meeting
- Be prepared for the unexpected and what that may be.
A problem with the device may require remedial action.
- Do you have a recall or a field correction procedure?
- When are you required to notify the FDA?
- What information is the FDA expecting to receive?
- What follow up actions are needed?
- Should you expect an FDA inspection as a result of this action?