Edwin Melendez

Edwin Melendez has been with the FDA for the past 23 years. He began his career with the FDA in 1983 at the San Juan District Office, experiencing a wide-variety of field work, including inspections of manufacturers in foods, drugs, devices, and biologics. In 1988, he was appointed to the drug pre-approval cadre. Later he became a member of the foreign inspection cadre and regularly conducted inspections of pharmaceutical firms worldwide. In 1993, he was promoted to Resident-In-Charge of the Mayaguez Resident Post, and in 1996, he was promoted to compliance officer of CDER's Office of Compliance, Division of Manufacturing and Product Quality, Foreign Inspection Team, at Rockville, Maryland. He served as an advisor to the Pan American Health Organization on drug cGMP training and inspection programs. In 2006, he was certified as a Level III Drug Investigator forming part of the Pharmaceutical Inspectorate cadre. Currently Melendez serves as a contact person for cross-contamination issues related to Beta-Lactams and Potent Compounds. He continues to conduct inspections of international and domestic pharmaceutical manufacturers for compliance with Drug cGMP regulations and policies. He also assists compliance officers and investigators evaluate foreign and domestic inspection activities in drug manufacturing operations for compliance with cGMP regulations and policies. Melendez worked as a QC/QA technician for a Johnson & Johnson drug/device manufacturer prior to his FDA career and has a Bachelor's degree in chemistry from the Inter-American University of Puerto Rico.