Responses to FDA-483 forms and Warning Letters and quality system

FDA has increasingly issued FDA-483 Observations and then turned to Warning Letters as a tool for voluntary compliance. Unfortunately, the types of issues FDA is including in FDA-483’s and Warning Letters makes mere compliance not sufficient, but rather the company must have state of the art quality systems. It is no longer sufficient to have a procedure and follow it. FDA may consider the procedure inadequate and evidence you follow the procedure may not be acceptable to FDA as you may have not done it up to the FDA requirements. Effective responses to FDA-483 Observations can prevent a Warning Letter, and effective responses to Warning Letters can prevent the famous “Sign or Sue Letter” from FDA (the infamous consent decree).