Episode Summary:

In this episode of FDA Imports: Cross-Border Compliance, host Sean O'Connor and attorney Benjamin L. England delve into the complexities of customs post-entry audits, focusing on CF-28s and CF-29s. Benjamin, founder of FDAImports.com and a former FDA regulatory counsel, explains why importers shouldn't assume their responsibilities end once a shipment clears customs. He highlights the importance of understanding the conditional nature of customs releases and the potential for audits years after entry. The discussion covers the differences between CF-28 and CF-29 forms, the types of issues that can trigger audits, and the implications of failing to comply with customs regulations. Benjamin also offers practical advice on maintaining proper documentation and the significance of a well-drafted purchase order to mitigate risks. This episode is essential for importers looking to navigate the intricate landscape of FDA and customs compliance effectively.

Key Timestamps:

00:01 – Introduction

00:07 – Overview of Customs Post-Entry Audits

00:53 – Conditional Release of Goods by Customs

01:58 – Role of FDA in Customs Compliance

03:08 – Customs Examination and Duty Calculation

04:41 – Understanding CF-28 Forms and Compliance

05:48 – Differences Between CF-28 and CF-29

07:42 – Triggers for Post-Entry Audits

10:26 – Record Keeping and Statute of Limitations

12:23 – Importance of Accurate Declarations

14:04 – FDA Involvement in Customs Investigations

16:08 – Systems to Reduce Post-Entry Audit Risks

About the Show:

FDA Imports: Cross-Border Compliance is a podcast designed for businesses navigating the complex world of FDA regulations and international trade. Hosted by industry experts, the show provides insights into compliance strategies, regulatory updates, and best practices for managing cross-border transactions. With a focus on clarity and practical advice, each episode aims to equip listeners with the knowledge they need to successfully import and export goods while adhering to legal requirements. Whether you're a seasoned importer or new to the field, this podcast offers valuable guidance to help you stay compliant and avoid costly pitfalls.