User account menu Search Menu Home About Quality Regulatory inspections Regulatory inspections We regularly participate in regulatory inspections to help ensure the highest quality in our operations in development, manufacturing and distribution. Health authority inspection programs were also impacted by the COVID-19 pandemic, with some inspections postponed or conducted remotely. Novartis was subject to 19 remote inspections, all of which had acceptable outcomes. Postponed inspections will be performed as soon as possible, based on a risk-benefit evaluation by the responsible health authority. A total of 126 inspections were completed in 2020 by external health authorities (e.g., FDA, EMA). All but one were found to be good or acceptable (99.2%). The one inspection that may require further improvement was due to increased inspection focus on our clinical activities. The final classification of this inspection by the health authority is still to be determined. All regulatory authorities 2016 2017 2018 2019 2020 Inspections 206 217 202 187 126 % Inspections considered acceptable 98.1 99.1 98.5 96.8 99.2 FDA inspections 26 30 18 19 6 FDA warning letters 0 0 0 0 0 FDA Form 483 14 14 8 11 1 FDA sponsor inspections 2016 2017 2018 2019 2020 Inspections related to clinical trial management and pharmacovigilance 5 5 3 2 1 Number of VAI (Voluntary Action Indicated) 1 2 1 1 0 Number of OAI (Official Action Indicated) 0 0 0 0 0 Related Links Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA Sandoz proposed biosimilar pegfilgrastim accepted by EMA for regulatory review Regulatory submission for Sandoz' proposed biosimilar pegfilgrastim accepted by the FDA FDA accepts Sandoz regulatory submission for a proposed biosimilar etanercept Novartis Navigate Patients and Caregivers Healthcare Professionals Researchers Job Seekers Journalists Investors Partners Suppliers Topics Clinical Trials COVID-19 Info Center ESG Explore Stories Diseases Locations Companies Sandoz Advanced Accelerator Applications Footer Bottom © 2021 Novartis AG Terms of Use Privacy Contacts Cookie Settings Site Map Novartis Site Directory This site is intended for a global audience