Introduction - Enforcement Story

Foreword

Throughout Fiscal Year 2004, the Food and Drug Administration (FDA) worked diligently enforcing the Federal Food, Drug and Cosmetic Act (Act). These efforts have resulted in significant enforcement accomplishments, including civil and criminal prosecutions, injunctions, and seizures, for violations of the Act and related statutes.

The Enforcement Story provides an overview of FDA's enforcement accom-plishments using the enforcements tools described above.

Contributors to The Enforcement Story include the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the Office of Criminal Investigations. Other contributors include the Office of Enforcement (OE) and Divisions within OE, including the Division of Compliance Policy, the Division of Compliance Management and Operations, and the Division of Information Management and Quality Assurance. Further sources of informa-tion include the Office of Public Affairs, the Program Evaluation Branch in the Office of Resource Management, the Division of Import Operations and Policy in the Office of Regional Operations, and the Office of the Chief Counsel. FDA field personnel contributed through their diligence, hard work and dedication in enforcing the Act.

The Enforcement Story describes examples of noncompliance by only a fraction ofregulated industry. The vast majority of industry share FDA’s commitment to the health and safety of the public and produceshigh quality, reliable products.

PURPOSE:

The information contained in this publication was obtained from many sources within the FDA throughout the course of the fiscal year and was updated until the time of publication. While reasonable steps were taken to assure the information was correct at the time of publication, the statements in the publication may not contain all significant information on any cited account.

Further, this publication does not include all enforcement actions undertaken by the FDA during the fiscal year. All items are presented in a summary form to convey the significance of the violation and /or court decision(s). The Enforcement Story is devoted to practical presentation of actual FDA enforce-ment actions that impact on the development, manufacture, distribution and marketing of foods, drugs, biologics, cosmetics and medical devices.

The Enforcement Story is intended as an internal publication to serve as an information source for the FDA’s personnel. The statements made herein are not intended to create or confer any rights, privileges, or benefits on or for any private person, but are intended merely for internal guidance.

DISTRIBUTION WITHIN THE FDA:

FDA personnel may obtain copies of The Enforcement Story by contacting the Division of Compliance Policy (HFC-230) in the ORA’s Office of Enforcement.

PUBLIC DISTRIBUTION:

The public may obtain a copy of The Enforcement Story by making a written Freedom of Information request.

COMMENTS:

Any comments as to how this annual publication may be improved are welcomed. Please send your comments to the Director, Division of Compliance Policy (HFC-230), 5600 Fishers Lane, Rockville, MD 20857.