FDA Prior Notice and PGA Holds at the San Diego Border
If you import food, drugs, cosmetics, devices, or supplements through Otay Mesa, a late or wrong FDA Prior Notice can strand your truck at the yard. We file it right, coordinate every partner agency, and keep your cargo moving.
What FDA Prior Notice and PGA coordination actually cover
FDA Prior Notice is the advance filing you owe the agency before an FDA-regulated shipment reaches the border. It applies to food and beverages, dietary supplements, drugs, medical devices, cosmetics, and radiation-emitting products. We transmit it through ACE alongside your entry, match it to the correct FDA product code, foreign facility registration, and manufacturer, and confirm the Prior Notice number before your driver rolls up to the crossing.
Prior Notice is one piece of a bigger picture. FDA, USDA, EPA, and other partner government agencies each ride the same ACE entry through their own message sets, and any one of them can flag your cargo for review. When the data is clean and complete, you get a “May Proceed.” When it is thin or contradictory, you get a Hold, an exam, or worse, a detention. Our job is to get the answer right the first time so your load is not sitting at Otay Mesa waiting on a correction.
What’s included
- ✓ FDA Prior Notice filing through ACE for food, drug, cosmetic, device, and supplement imports, with the confirmation number verified before arrival
- ✓ Correct timing per mode: for truck crossings at Otay Mesa, no more than 30 days and no less than 2 hours before the cargo reaches the port
- ✓ Accurate FDA product coding, affirmations of compliance, and matching to the foreign facility registration and manufacturer of record
- ✓ Partner government agency coordination across FDA, USDA APHIS and FSIS, EPA, and others on the same entry
- ✓ FSVP review support so your Foreign Supplier Verification Program records line up with what we declare
- ✓ Fast response to FDA and USDA Hold, exam, and sampling notices, including document requests and lab result follow-up
- ✓ Guidance on Detention Without Physical Examination and Import Alert situations, plus what it takes to get off the list
- ✓ Bilingual coordination with your Mexican shipper so facility and product data is right before the truck loads
How we handle it
Confirm what is regulated
We review your commercial invoice and product details to identify every FDA and PGA touch point, so nothing gets missed and nothing gets over-declared.
File Prior Notice and the entry together
We transmit Prior Notice and the ACE entry with correct product codes, affirmations, and facility data, then verify the confirmation number before the truck approaches the border.
Clear the agency review
If FDA or USDA flags the load, we respond fast with the documents, labels, or samples they need and push for a May Proceed instead of a stalled truck.
Close out and protect the next one
We log what triggered any review and tighten your data for future shipments, so recurring imports clear cleaner and your supplier records stay audit-ready.