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Crisis Intervention Services for FDA 483 & FDA Audits

Crisis Intervention Service

Are YOU presently concerned or involved in any of the following?

  • Recently received a notice of a forthcoming FDA audit
  • Received an FDA Warning Letter
  • Received non-conforming observations from an FDA audit (483)
  • Thinking about implementing a Corrective Action or Product Recall
  • Undergoing a Clinical Trial Investigation
  • FDA 483 Response Consulting


It is important that you prepare and respond to each of these situations carefully and thoughtfully. Failure to properly act in these situations could possibly result in your business being shut down, criminal/civil actions being filed against you or your company, and/or huge financial losses. We have seen many companies proceed without guidance and have ended up wasting a lot of time and money by not involving expert assistance during these critical situations.

mdi Consultants is the recognized industry leader in assisting healthcare companies out of crisis situations. Since time is critical, mdi Consultants has created an emergency hotline, which can provide you some initial assistance in understanding what is going on and how to proceed.

EMERGENCY HOTLINE

Our emergency hotline phone number is  +1 (516) 482-9001.
You can also send us an e-mail at crisis@mdiconsultants.com

This initial consultation of up to one hour will be done at NO CHARGE. After the first hour, a fee will be discussed and approved. If you are not satisfied with mdi’s services, you may cancel at any time and pay for only the time you used.

Sample Situations

Given that specific situations will vary from one client to another, below we have provided situations that are representative of companies that we have helped out of a crisis and the results we have helped them achieve.

Situation #1 – Postpone an FDA audit

The FDA just contacted you to let you know that they intend to inspect you facility next week; you are not sure why they are coming and if you would be able to pass the inspection. . If you get mdi involved immediately, mdi may be able to get an extension for the upcoming audit. mdi will ask the FDA certain questions to ascertain the FDA’s objectives with their audit. Based on the response of the FDA, we can help you to craft a strategy to have the audit postponed or to prepare for the audit itself. This can be especially useful for non-U.S. manufacturers, where the FDA gives up to 30 days notice of an upcoming inspection. Prior to the FDA audit, we can conduct a mock FDA inspection and provide you with a list of action items that have to be addressed, so you are better prepared for the official visit. At your request, mdi can also be present during the FDA inspection to ensure that the inspection proceeds properly and to assist in providing immediate strategies for addressing problems that the FDA finds. It is our experience that mdi’s presences during an FDA inspection is well received by the FDA and can greatly reduce the inspection time and increases the chances for a positive outcome of the inspection.

Situation #2 – Respond to an FDA Audit / FDA 483 Response

The FDA just finished their inspection and you just received a FDA 483, the FDA’s List of Observations. This List of Observations contains deviations that the FDA found during their visit. mdi will provide you with an explanation of these deviations, what their implications might be, and what regulatory actions the FDA may likely take against your company (i.e. Warning Letters, Seizure, Injunction). A proper response to a FDA 483 must be done within a matter of days and must be written in a specific manner to greatly reduce the likelihood of receiving a Warning Letter in the future. For non-U.S. manufacturers, the issuance of a Warning Letter could lead to an import alert which requires an automatic product detention of all shipments of products coming from your company into the U.S.

Situation #3 – Respond to an FDA Warning Letter

The issuance of a Warning Letter is a very serious violation and should not be taken lightly. Your response to the Warning Letter has to be made in such a way to provide a good understanding of the situation, but it has to address the actions that your company has taken or will take to assure compliance. mdi will provide you guidance in reviewing the Warning Letter, determining what underlying concerns there might be and provide a strategic plan on how to respond to the letter. The decision to meet with the FDA, at this time, may very well be warranted. These options, as well as all others, could be discussed.

Situation #4 – Health Hazard Analysis Response – Product Removal or Corrective Action (To notify the FDA or not)?

You have found out that there is a problem with your product. It has injured someone or you believe that it could injury someone. Now what do you do? Understanding the problem, brainstorming corrective actions, and performing an FMEA should all be done before you take any external actions. You must be prepared to act and have a logical strategy to give to the FDA. We will help you to identifying your options, correctly assess the FDA’s concerns, respond to the Health Hazard Analysis, and prepare for a pending FDA visit.

Situation #5 – MDR filing

This seems to be one of the biggest concerns a company has to deal with. What is an MDR (medical device reporting)? Do you have to file an MDR? What are the time frames for filing the report? We will help you to understand when you have to file an MDR, what needs to be included and how you should file it. This is particularly critical when you have Clinical Investigation Problems, since the economic ramifications of this type of problem can be devastating – especially to a small company. We can help you to identify your options and communicate with the FDA to keep your study open.