FDA's enforcement authority reaches its most consequential expression in judicial actions — cases where the agency and the Department of Justice take matters to federal court. Injunctions can shut down entire manufacturing operations. Seizures rem
Food and Drug Law: Imports and Exports Guide
All FDA-regulated products imported into the United States must meet the same laws and regulations as domestic goods. There is no lower standard for imported products. A food product manufactured in another country and offered for import at a US p
Food and Drug Law: Criminal Acts and Violations
The Federal Food, Drug, and Cosmetic Act (FDCA) contains a criminal enforcement framework that is unusual in US law: it allows conviction for certain offenses without proof of intent. A corporate executive can be found guilty of a federal crime be
FDA Field Examinations: Legal Authority & Compliance
Legal Disclaimer: This article is general educational information about FDA field examination law and regulations. It is not legal advice. Manufacturers facing an active inspection, warning letter, or enforcement action should consult a qualified re
FDA Good Guidance Practices: 10 Tips for Compliance
FDA guidance documents tell you what the FDA currently thinks. They do not tell you what you must do. Understanding that distinction, and knowing how to work with it rather than around it, is one of the more practically useful skills in regulatory a
FDA EIR Writing: 15 Practice Questions
The Establishment Inspection Report (EIR) is the FDA investigator's official record of an inspection: a comprehensive internal narrative that documents everything observed, reviewed, and discussed during a facility visit, and recommends how the in
FDA Establishment Inspections: A Complete Guide
An FDA establishment inspection (EI) is a careful, critical, official examination of a facility to determine its compliance with laws enforced by the FDA. For any pharmaceutical manufacturer, medical device maker, biologics producer, or other FDA-
Failure Investigations for Medical Device Makers
Failure investigations are the point at which a medical device manufacturer's quality system either demonstrates genuine effectiveness or reveals its limitations. They are among the most consistently cited areas in FDA medical device inspections,