PGA & FDA Hold Prevention

Client

A U.S. importer of regulated consumer products distributing goods through retail and e-commerce channels across the United States.

Challenge

The client experienced frequent entry holds and clearance delays due to Partner Government Agency (PGA) requirements, particularly with FDA-regulated products. Missing data elements, inconsistent product descriptions, and incomplete documentation from overseas suppliers often triggered additional reviews by Customs and FDA.

These delays resulted in extended cargo dwell time at the port, increased storage and exam-related costs, and disruption to the client’s delivery schedules. The client needed a more structured process to ensure that the required data and documentation were accurate and complete before shipments arrived in the United States.

Solution

J.M. Rodgers conducted a review of the client’s import process and implemented several improvements to strengthen compliance and clearance efficiency:

• Reviewed product requirements, FDA applicability, and required entry data elements
• Implemented standardized documentation templates to ensure consistent product descriptions and required regulatory information
• Coordinated with overseas suppliers to align commercial invoices and supporting documents with FDA reporting requirements
• Introduced a pre-arrival review process for higher-risk SKUs to confirm compliance before shipments departed origin
• Established a consistent workflow for handling FDA/PGA-related shipments within the customs brokerage process

Outcome

Reduced PGA/FDA holds and improved cargo release times

• Lower storage, exam, and delay-related costs
• More predictable cargo flow through U.S. ports
• Improved delivery reliability for the client’s distribution network

Key takeaways

• PGA compliance is largely a data and documentation process, not simply a customs clearance issue
• Early coordination with suppliers helps ensure entry information meets regulatory requirements
• Pre-arrival review significantly reduces the risk of costly delays once cargo reaches the port