FDA EIR - Exela Pharma Sciences LLC - July 18, 2019

An FDA inspection of Exela Pharma Sciences, LLC, an outsourcing facility in Lenoir, NC, took place from June 10 to July 18, 2019. Conducted under Section 503B of the Food, Drug, and Cosmetic Act and current Good Manufacturing Practices, the inspection uncovered significant issues, leading to a 7-item FDA Form 483 and a recommendation for Official Action Indicated classification. Major violations included operators demonstrating poor aseptic technique during sterile drug product filling, and a deficient environmental monitoring system. Aseptic processes lacked adequate validation, and certain containers/closures, specifically IV bags for Sodium Chloride, were found inappropriate for their intended use. The company ’s quality investigations were insufficient, batch records were incomplete, and critical equipment was not properly maintained. Additional verbal observations raised concerns about pressure differential monitoring, material storage in aseptic areas, and raw material label control. Specific 503B-related issues, such as verifying drug shortages and supplier registrations, also required attention. Exela Pharma Sciences, LLC committed to responding to the FDA Form 483 within 15 business days, detailing their corrective actions to address these serious findings.