End-To-End FDA Import Timeline
Where Delays Happen and How to Avoid Them
Follow this 9-step path to keep your shipment moving, from pre-entry planning to final release. Click any stage to learn more.
Product & Tariff Prep
- Assign the correct HTS code to avoid unexpected duties.
- Check country-of-origin rules and tariff exclusions.
Supplier Documentation
- Collect COAs, FSVP records, and supplier audit results.
- Confirm product labels and ingredients meet U.S. requirements.
Entry Submission
Errors that trigger delays:
- Inadequate timing for Prior Notice
- Incorrect product code.
- Missing FCE/SID (LACF) or other registration number.
- Wrong affirmation-of-compliance code.
- Manufacturer/shipper mismatch.
- Incomplete entry-line data (quantity, UOM, description).
Arrival & Risk Scoring
- FDA’s PREDICT algorithm ranks shipment risk on arrival.
- Expect a Notice of Action within 24 hours if flagged.
Detention & FDA Sampling
If your shipment is detained:
- Carefully read the FDA Notice of Action and note the respond-by date.
- Gather all supporting entry documentation for the private lab (Certified Group) to sample and test product following FDA protocol.
- Communicate intentions for the entry with the FDA compliance officer.
Laboratory Testing (Certified Group)
- ISO 17025- and LAAF-accredited; validated methods align with FDA requirements.
- Chemistry, Microbiological, Filth, Decomposition Analysis
ITACS Document Submission
- Submit lab package through ITACS for FDA review —
Certified Group can do this for you.
FDA Decision — Release, Recondition, or Refusal
- FDA may release the lot, approve a reconditioning plan, or refuse admission.
- Refused product must be destroyed or exported under CBP/FDA supervision.
Continuous Compliance
- Maintain your FSVP & supplier verifications.
- Track Import Alerts relevant to your products and facilities.
- If you appear on a Red List, Certified Group can petition for removal, which requires five consecutive clean shipments.
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