Reviewing your regulated entries
If the same thing keeps happening to your shipments, it is usually visible in the entries. Somebody has to look across them rather than at them one at a time.
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An FDA entry compliance review examines an importer's past regulated entries as a set rather than individually. It checks whether product codes were applied consistently, whether affirmations were appropriate, whether registration and party data were accurate, and whether holds or examinations follow a pattern that points at a fixable cause.
Key takeaways
- Patterns are invisible entry by entry and obvious across a year of them.
- Inconsistent product codes for one product attract attention over time.
- Recurring holds usually have a single underlying cause.
- Importers must retain entry records, so the material generally exists.
- Findings are only useful if the corrections carry into future filings.
What a review looks at
Whether the same product was coded the same way each time. Whether affirmations of compliance were appropriate and consistently applied. Whether manufacturer and registration data stayed accurate as suppliers changed. Whether Prior Notice and FSVP data were complete. And whether holds, examinations or document requests cluster around a particular product, supplier, port or period.
Why the pattern matters more than any single entry
One hold is an event. Four holds on the same product across a year is a cause, and it is usually something small and fixable that nobody had the vantage point to notice — a code applied inconsistently, a supplier whose registration lapsed, a description that reads differently to a reviewer than it does to you.
How it works
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01
Scope agreed
Which entries, which period, and what you are trying to understand.
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02
Records assembled
From your files and, where we filed them, from ours.
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03
Data compared
Codes, affirmations, party details and registration data across the set.
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04
Incidents mapped
Holds, exams, requests and detentions plotted against product and supplier.
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05
Findings reported
What is happening, why, and what would change it.
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06
Corrections carried forward
Applied to future filings, which is the only part that matters commercially.
Common mistakes
- Reviewing entries one at a time. The pattern is the point, and it is invisible at that level.
- Only looking after something goes badly wrong. The pattern was there for months beforehand.
- Fixing the finding but not the process. The same error returns on the next shipment.
- Assuming a new broker inherits the history. They inherit the consequences, not the file.
- Poor record retention. Importers must keep entry records; without them there is nothing to review.
Questions
When is a review worth doing?
When shipments are repeatedly held or examined, when suppliers or products have changed materially, before scaling volume, or after switching brokers and wanting to know what was inherited.
How far back should it go?
Importers are required to retain entry records for five years. A review commonly covers twelve to twenty-four months, which is usually enough for patterns to appear.
Will this find problems I have to disclose?
It may identify errors in past filings. What to do about those depends on the nature and materiality, and in some circumstances that is a question for counsel rather than for a broker. We will tell you plainly when that line is reached.
Can you review entries another broker filed?
Yes. That is a common reason for a review — understanding what you have taken on.
Related
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start.