Warning Letter Response and Remediation

Have You Received a Warning Letter from the FDA?

Has the FDA Deemed Your Response “Not Adequate?”

Just one quick glance at the recent Warning Letters issued by the FDA and you will see an all too common response from the FDA…

“We reviewed your firm’s response and concluded that it is not adequate.”

Warning Letter Response and Remediation Services

FDA Warning Letter MitigationIf this has happened to you, MBCA’s warning letter response and remediation services may be right for you.  Do not try to respond on your own unless you have extensive expertise in responding to the FDA.  MBCA can help you develop proven responses that will give you time to implement the short and long term remediation and corrective actions the FDA demands.  There is a right and a wrong way to respond to FDA warning letters.  MBCA’s FDA regulatory compliance consulting expert will help you formulate the correct response for your situation.

Responding to the FDA is only half the battle.  MBCA will help sort it out and provide you with a clear remediation and corrective action plan for moving forward.  MBCA will not just give you advice but will help you implement the specific actions you need to clear your company of the warning letter quickly.  As an added bonus, MBCA always focuses on creating business value that improves your company’s performance along the way.  You get much more than simple compliance.

Any medical device company can find themselves staring at a warning letter (or worse).  Let MBCA help today!

Ms. Ball, Principal Consultant has 23+ years’ experience and a proven track record to get you out of the FDA spotlight quickly and get you back to your normal business operations.

FDA Compliance Services include:

  • FDA 483 Responses
  • Untitled Letter responses
  • Warning Letter responses and corrective action plans
  • Remediation


Schedule FREE 30-min Consultation Now »