Mr. Luis Chavarria recently retired from the United States Food and Drug Administration (FDA) after more than 30 years of service. His unique career covered numerous national and international assignments. Starting with the position of Consumer Safety Inspector and ending with the position of Assistant Regional Director for Latin America in the Office of the Commissioner.
He worked in numerous offices and held numerous positions such as Consumer Safety Inspector, Consumer Safety Investigator, Supervisory Consumer Safety Investigator, Drug and Device Specialist, Program Analyst and Diplomat. He was the first foreign- based FDA attaché in the United States Embassy in Mexico City, representing the FDA in all program areas.
With more than 28 years experience with the FDA Office of Regulatory Affairs, he knows how the agency conducts inspections in all program areas and how regulatory actions are developed within the agency and within the court system. He personally conducted numerous inspections and investigations resulting in legal actions by the agency.
The presentation will cover all the regulatory steps involved in the importation of FDA regulated products as they apply to FDA and Customs and Border protection at the ports of entry. Recorded
The presentation will cover important documents such as the Establishment Inspection Report, and the FDA Notice of Observations. The presentation will also cover the different steps the investigator takes after he/she finishes the inspection and writes the Establishment Inspection Report in the various programs used by the agency to track inspection reports and regulatory considerations. Recorded