With the advent of only 15 calendar days to respond to regulators following a Form FDA 483 or Warning Letter, it is incumbent upon the recipients of these to use the time most productively to minimize any further regulatory actions.

Understanding the Observation becomes the initial step.  Unless the individuals are responding with a thorough understanding, this first receipt of any document by the regulators can be quite devastating since a less than complete or scientifically developed response can create additional regulatory actions.

Understanding what to include within the response goes a long way to assuring the regulatory agency that you understand the Observation(s) and that you are taking immediate actions to comply with their requirements.

Expert Witness Consultation

Whether you are the plaintiff or the defendant within a legal action, there often exists extensive documentation that may require additional examination.  Using my regulatory compliance background — especially in the areas of Quality Compliance, aseptic processing, sterility assurance and microbiology, I can provide explanations and answers to the regulatory commentary that is expected.

Please contact me at barryafriedman@aol.com or 410.654.3636 for an initial consultation