Ileana Barreto-Pettit Parexel

Ileana Barreto-Pettit

Ileana Barreto-Pettit Parexel Vice President, Technical Strategic Compliance

During her 24-year tenure at the U.S. Food and Drug Administration, Ms. Barreto-Pettit has held various roles, including her most recent position as Drug National Expert within the Office of Regulatory Affairs (ORA). She is considered a Subject Matter Expert (SME) in the FDA’s inspectional process, GMP regulations and expectations, and compliance programs and policies.  Throughout her career, she has conducted hundreds of domestic and international inspections of sterile and non-sterile drug manufacturers where she identified significant GMP deficiencies resulting in compliance actions. These actions have included the immediate cessation of production operations, the issuance of Warning Letters and Import Alerts, as well as injunctions, seizures, destructions, and recalls of adulterated drug products. Barreto-Pettit has extensive knowledge and understanding of Good Manufacturing Practice (GMP) regulations and their applicability to sterile and non-sterile drug manufacturing processes.  She has served as a Senior Trainer in the FDA Drug School for 17 years. In this role, she has trained hundreds of new drug investigators, compliance officers, chemists, microbiologists, and drug application reviewers on 21 CFR 211 regulations and the ORA inspectional process. Furthermore, Ms. Barreto-Pettit has represented the FDA as an SME in various agency, national, and international groups and organizations. She has also played an instrumental role in the revision of international inspectional documents which are utilized by GMP regulators from multiple countries. Barreto-Pettit is currently a VP-Technical with Parexel International where she is utilizing her FDA investigational experience to assist drug manufacturing companies in preparing for FDA inspections and implement effective corrective and preventive actions. Her goal is to assist companies in achieving sustainable GMP compliance to ensure drug products are safe and effective, and drug shortages are prevented.