How To Respond To A FDA Inspection And Warning Letter

Why Should You Attend:

Anyone in the food and drug business must know the rights of the FDA, the firm and individuals employed by the firm when the FDA, unannounced, appears to conduct an inspection of the facility. This 2-hr webinar will help you understand the right the FDA has to conduct an inspection of upon demand of a facility under FDA jurisdiction, the rights of the firm and individuals when FDA does conduct an inspection.

If the FDA investigator starts taking photographs, what is the best response for the firm to take? May an individual assert his/her Constitutional rights under the Fifth Amendment to questions put by an investigator? How should an individual respond if a FDA investigator appears at his/her private residence at night asking questions about the FDA regulated firm that employees the individual?

All of the possible issues that may come up during an inspection need to be answered before an inspection occurs, and the individuals who escort the FDA investigators must be trained to know what to do. This 120-minute training will give you the necessary information to be fully prepared for an inspection, a FDA 483 and a Warning Letter. The speaker will give you the tools to protect the interests of your firm and individuals, including what to do when a rogue investigator acts inappropriately in an inspection.

Areas Covered in the Seminar:

• The right of the FDA to conduct an inspection of a FDA regulated firm without any search warrant or administrative warrant.
• The scope an FDA investigation can take, which in part depends on which FDA regulated product is the subject of the investigation
• How FDA decides on which firm(s) to inspect.
• What the FDA is required to do upon arrival at the firm to conduct a lawful inspection?
• What the firm's initial response to FDA's demand for an inspection should be?
• What the firm should do to prepare for the inspection, both for the company as well as for individual employees?
• The significance of the “responsible” person in a FDA inspection under a statute that allows for prosecution of a non-intent crime and why individuals at FDA regulated firms should understand how important it is to know what to do and not do.
• What the individuals who escort the FDA investigators during the inspection should do and not do in response to FDA questions, demands, inquiries, and conduct. Consider this an exercise in practical applications.
• FDA 483 list of observations, what it means, how to respond to it in the exit interview and what to do to respond to the FDA 483.  Within this part of the presentation the exit interview will be so individuals especially will know how to present at an exit interview.
• What the firm should do to respond to a warning letter to avoid any enforcement action?
• Several hypothetical situations that may well occur during an inspection and determine the correct course of action

Who Will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Compliance/Regulatory affairs professionals
• QA/QC professionals
• Senior management executives (CEO, COO, CFO, etc)
• Manufacturing managers, supervisors & personnel
• Project Managers

Instructor Profile:

Charles R. (Bob) McConachie, is a Dallas, Tx attorney. He has practiced food and drug law beginning in 1970 at the Department of Justice where he litigated FDA enforcement and regulatory law cases in federal courts. From 1975 to 1979 he served as Chief of the Consumer Affairs Section, now the Consumer Protection Division of the Civil Division at DOJ. Among other cases he personally argued the case in which the FDA’s decision to remove Red Dye No. 2 from the market by the end of the day was upheld by the DC Circuit.

In private practice since 1980 Mr. McConachie has advised food and drug clients on many aspects of food and drug law including compliance with FDA law and regulation of drugs, devices, food and food supplements. From 1982 until 2006 he served as an adjunct professor at SMU School of Law teaching the Food and Drug Law course. As a speaker Mr. McConachie has made presentations at FDLI and State Bar of Texas educational conferences on numerous occasions. Mr McConachie received the BBA degree from The University of Texas and the JD degree from St. Mary’s University of San Antonio.

Topic Background:

Every firm that manufactures, distributes, holds or sells products regulated by FDA is subject to being inspected by FDA at any reasonable time. How the notice of inspection is prepared for and handled, questions answered, responses for demands for information and documents and general demeanor will often determine whether a FDA 483 is issued or a Warning Letter sent. Since the individuals who escort the FDA investigators during the inspection are often responsible individuals under FDA procedures it is important that they be fully trained if only to not be named defendants should the government wish to pursue a criminal prosecution where the maximum penalty is $1,000 and jail of up to one year or both, or a civil penalty, a civil seizure action and/or an injunction action.

The goal of the firm being inspected is to have the FDA investigators not issue a FDA 483 list of observations at the end of the investigation. Where a FDA 483 is issued the firm has to know how to respond to avoid being sent a Warning Letter. Should a Warning Letter be issued the firm must be able to make an adequate and timely response to FDA to avoid one of the enforcement actions the FDA will choose to pursue.

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