Preparing for an FDA Virtual Audit — The Best Practices

Since the Pandemic became global in 2020, the FDA has been requesting documents from firms in advance of or in lieu of an inspection. This authority comes from the Federal Food, Drug and Cosmetic Act (FD&C Act) in Section 704(a)(4). However, while they have not adopted doing a remote inspection in place of an onsite … Continue reading Preparing for an FDA Virtual Audit — The Best Practices